Ebanga Ansuvimab 400 mg/8mL Injection, Powder, Lyophilized, For Solution — NDC 71655-578-03 (Billing 71655-0578-03)
This is a package of Ebanga Ansuvimab 400 mg/8mL Injection, Powder, Lyophilized, For Solution from Emergent BioDefense Operations Lansing LLC, marketed since Dec 2020 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.
NDC database record
One package, one record: these facts belong to NDC 71655-578-03 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 71655 labeler · 578 product · 03 package
- Package marketed since
- Dec 21, 2020
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 7165557803 0
- FDA record last changed
- Aug 27, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 081835
- GCN: 49067
- HICL (First Databank): 047062
- AHFS class code: 08:18.24.00
- RxCUI (RxNorm): 2472156
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Zaire Ebolavirus Glycoprotein-directed Antibody class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 8, 2026
Clinical
- Ebanga is the brand name for ansuvimab — a lab-made antibody designed specifically to fight Ebola virus disease caused by the Zaire strain of Ebola. It's approved for adults, child...
- What exactly is Ebanga and what is it used for?
- Neither — it's given as an IV infusion directly into a vein, over about 60 minutes, once. You won't be preparing or taking anything at home. A healthcare team handles everything: d...
- How is Ebanga given — do I take a pill or get a shot?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 9, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 71655-0578-03 You're viewing this Main listing | 1 CARTON in 1 BOX / 36 VIAL, GLASS in 1 CARTON / 8 mL in 1 VIAL, GLASS | 2020-12-21 | — | Active |
| 71655-0578-04 71655-578-04 | 4 CARTON in 1 BOX / 36 VIAL, GLASS in 1 CARTON / 8 mL in 1 VIAL, GLASS | 2020-12-21 | — | Active |
| 71655-0578-08 71655-578-08 | 8 CARTON in 1 BOX / 36 VIAL, GLASS in 1 CARTON / 8 mL in 1 VIAL, GLASS | 2020-12-21 | — | Active |
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Ebanga Ansuvimab 400 mg/8mL Injection, Powder, Lyophilized, For Solution?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ebanga 400 mg/8mLthis 71655-0578-03 | Emergent | 36 vials | — | — | FDA listed | — |
| Ebanga 80673-0777-01 | Ridgeback | 1 kit | — | — | Discontinued | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Dec 21, 2032 |
Is there a biosimilar for EBANGA 400 MG VIAL (STOCKPILE)?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
- FDA Purple Book · refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Ansuvimab inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 4QD397987E
An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
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UNII 1D5Q932XM6
An amino acid salt used in medicines as a buffer and pH regulator. It helps maintain the proper acidity level in liquid formulations to keep the drug stable and effective.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Emergent BioDefense Operations Lansing LLC labeler code 71655
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE EBANGA is indicated for the treatment of infection caused by Orthoebolavirus zairense (formerly Zaire ebolavirus) in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2) and Clinical Studies (14) ]. EBANGA (ansuvimab-zykl) is an Orthoebolavirus zairense glycoprotein (EBOV GP)-directed human monoclonal antibody indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection.
( 1 ) Limitation of Use The efficacy of EBANGA has not been established for other species of the Orthoebolavirus and Orthomarburgvirus genera . Orthoebolavirus zairense can change over time, and factors such as emergence of resistance or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating Orthoebolavirus zairense strains when deciding whether to use EBANGA.
Limitations of Use: The efficacy of EBANGA has not been established for other species of the Orthoebolavirus and Orthomarburgvirus genera. Orthoebolavirus zairense can change over time, and factors such as emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating Orthoebolavirus zairense strains when deciding whether to use EBANGA.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommended dose of EBANGA for adult and pediatric patients is 50 mg/kg reconstituted, further diluted, and administered as a single intravenous infusion over 60 minutes. ( 2.1 , 2.2 ) See Full Prescribing Information for instructions on preparation, dilution and administration of EBANGA injection. ( 2.2 )
2.1Recommended Dosage for Adult and Pediatric Patients The recommended dosage of EBANGA is 50 mg/kg administered as a single intravenous (IV) infusion over 60 minutes. EBANGA must be reconstituted with Sterile Water for Injection, USP then further diluted in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP prior to IV infusion [see Dosage and Administration (2.2) ] . 2.2.
Preparation, Administration, and Storage Instructions EBANGA must be prepared and administered under the supervision of a health care professional. Reconstitution Instructions Aseptically reconstitute and further dilute EBANGA prior to IV infusion. Do not administer as an IV push or bolus.
More than one vial may be needed for a full dose. Calculate the dose (mg) based on the patient’s actual weight in kg and the number of EBANGA vials required [see Dosage and Administration (2.1) ] . Prior to reconstitution, allow EBANGA vial(s) to reach ambient temperature (15°C to 27°C [59°F to 81°F]) for approximately 20 minutes.
If for any reason reconstitution cannot proceed immediately upon reaching ambient temperature, vials that have NOT been reconstituted may be kept at ambient temperature, protected from light, for no more than 24 hours. Immediately upon reaching ambient temperature, use a sterile 10 mL syringe and an 18-gauge needle to withdraw 7.7 mL of Sterile Water for Injection, USP. Insert the needle tip into the EBANGA vial.
Holding horizontally, angle the needle down at an approximate 45° angle, above the lyophilized powder, which has a cake-like appearance. Slowly inject the diluent along the wall of the vial and without any air to avoid foaming and bubbles. Gently swirl (do NOT shake) for approximately 10 seconds; then set the vial down to rest for at least 10 seconds.
Repeat until the cake is dissolved. This may take up to 20 minutes. Upon reconstitution, one vial delivers 8 mL of solution that is clear to slightly opalescent and colorless to slightly yellow containing 50 mg/mL of ansuvimab-zykl.
Do NOT administer and discard the vial if the reconstituted solution is discolored or contains visible particles. Dilute the EBANGA solution immediately upon reconstitution. If needed, the reconstituted solution may be stored refrigerated at 2°C to 8°C (36°F to 46°F), protected from light, for up to 4 hours.
This 4-hour window includes time required for further dilution and EBANGA solution should be infused immediately upon further dilution. Dilution Instructions Following reconstitution, EBANGA must be further diluted prior to IV infusion. Use an 18-20 gauge, 1-1.5” needle with an appropriately sized syringe up to 60 mL to perform the dilution steps.
Prepare the EBANGA IV dosing solution using an appropriately sized syringe up to 60 mL. For patients weighing ≥ 2 kg, prepare the diluent using either a latex-free, di-ethylhexylphthalate (DEHP)-free 0.9% Sodium Chloride Injection USP infusion bag, or latex-free, DEHP-free 5% Dextrose Injection USP infusion bag. For patients weighing 0.5 to < 2 kg use a pump-compatible syringe ( Table 1 ).
For adult and pediatric patients, either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP can be used as the diluent. The total volume of the infusion solution to be administered is based on the patient’s body weight and is specified in Table 1 . For patients weighing 0.5 to < 2 kg: Use a 10 mL syringe compatible with the IV infusion pump.
Fill the 10 mL syringe with the appropriate amount of diluent ( Table 1 ). Add the calculated volume of EBANGA to the 10 mL syringe ( Table 1 ). Mix the diluted solution by gentle inversion (3 to 5 times) until admixed.
Do not… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS For injection: 400 mg of ansuvimab-zykl, available as an off-white to white lyophilized powder in single-dose vial for reconstitution and further dilution. For injection: 400 mg lyophilized powder in a single-dose vial for reconstitution and further dilution. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None . None.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Including Infusion-Associated Events: Hypersensitivity reactions including infusion-associated events have been reported with EBANGA. These may include acute, life- threatening reactions during and after the infusion. Monitor patients and in the case of severe or life-threatening hypersensitivity reactions, discontinue the administration of EBANGA immediately and administer appropriate emergency care.
( 5.1 )
5.1Hypersensitivity Reactions Including Infusion-Associated Events Hypersensitivity reactions including infusion-associated events have been reported with EBANGA. These may include acute, life-threatening reactions during and after the infusion. Monitor all patients for signs and symptoms including, but not limited to, hypotension, chills and elevation of fever, during and following EBANGA infusion.
In the case of severe or life-threatening hypersensitivity reactions, discontinue the administration of EBANGA immediately and administer appropriate emergency care [see Adverse Reactions (6.1) ]. Infusion could not be completed in 1% of participants who received EBANGA due to infusion-associated adverse events. The rate of infusion of EBANGA may be slowed or interrupted if the patient develops any signs of infusion-associated events or other adverse events [see Adverse Reactions (6.1) ].
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Including Infusion-Associated Events [see Warnings and Precautions (5.1) ] The most frequently reported adverse events (≥ 5%) after administration of EBANGA were pyrexia, tachycardia, diarrhea, vomiting, hypotension, tachypnea, and chills. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Emergent BioSolutions at 1-800-768-2304 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice. Overall, 424 adult and pediatric participants with Orthoebolavirus zairense infection received EBANGA in one clinical trial and as part of an expanded access program during the 2018 Orthoebolavirus zairense outbreak in the Democratic Republic of Congo (DRC). In the PALM trial, the safety of EBANGA was evaluated in a multi-center, open-label, randomized controlled trial, in which 173 participants (119 adults and 54 pediatric participants) with confirmed Orthoebolavirus zairense infection received EBANGA as a single 50 mg/kg IV infusion and 168 participants received an investigational control [see Clinical Studies (14) ] .
All participants received optimized standard of care treatment (oSOC). The median age of the study population that received EBANGA was 26 years (range: 1 day to 85 years) and 55% were female. During the same outbreak, 251 participants (173 adults and 78 pediatric participants) with laboratory-confirmed Orthoebolavirus zairense infection received EBANGA under an expanded access program, 57% of whom were female.
Ages ranged from 6 days to 80 years, with a median age of 25 years. Common Adverse Events Table 2 summarizes the adverse events that were reported in the PALM trial from a pre-defined list of signs and symptoms that occurred during EBANGA infusion. The evaluation of adverse events in participants who received EBANGA may have been confounded by the signs and symptoms of the underlying Orthoebolavirus zairense infection.
Twenty nine percent (n=51) of participants who received EBANGA in the PALM Trial experienced a pre-specified infusion-related adverse event. The most common pre-specified infusion-related adverse event reported in at least 10% of participants who received EBANGA was fever ( Table 2 ). The adverse event profile in adult and pediatric participants treated with EBANGA was similar.
Table 2 Adverse Events That Occurred During Infusion in >10% of Adult and Pediatric Participants in the PALM Trial Adverse Event a EBANGA (N=173) % Control b (N=168) % a Adverse events in this table were reported on the day of infusion, and included signs and symptoms that occurred during or immediately after infusion b Investigational therapy administered as three separate infusions c Adverse events that occurred during infusion but were not pre-specified. d The term chills includes other similar adverse events including rigors and tremors Pyrexia 17 58 Tachycardia 9 32 Diarrhea c 9 18 Vomiting c 8 23 Hypotension 8 31 Tachypnea 6 28 Chills d 5 33 Hypoxia c 3 11 The following pre-specified symptoms, which were assessed on a daily basis during admission while admitted to the treatment unit, were reported in ≥40% of participants who received EBANGA: diarrhea, pyrexia, abdominal pain, and vomiting.
Evaluation of these symptoms may have been confounded by the underlying Orthoebolavirus zairense infection. Discontinuation and Infusion Rate Adjustments Approximately 99% of participants who received EBANGA in the PALM trial were able to complete their dose within one hour. Two participants who received EBANGA (1%) did not receive their complete infusion.
In eight participants (5%) the EBANGA infusion rate was decreased due to an AE [see Warnings and Precautions (5.1) ] . Selected Laboratory Abnormalities… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Interaction with live vaccine indicated for prevention of Orthoebolavirus zairense infection: No vaccine interaction studies have been performed. EBANGA may reduce the efficacy of the live vaccine. The interval between administration of EBANGA therapy and live vaccination should be in accordance with current vaccination guidelines. ( 7.1 )
7.1Vaccine Interactions No vaccine-therapeutic interaction studies have been performed in human participants using EBANGA. However, because of the potential for EBANGA to inhibit replication of a live vaccine virus indicated for prevention of Orthoebolavirus zairense infection and possibly reduce the efficacy of the vaccine, avoid the concurrent administration of a live vaccine during treatment with EBANGA. The interval between administration of EBANGA therapy and live vaccination should be in accordance with current vaccination guidelines.
The efficacy of EBANGA among participants who reported receipt of a recombinant live vaccine prior to their enrollment in the PALM trial was similar to participants who did not report receiving a vaccine prior to enrollment.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Patients infected with Orthoebolavirus zairense should be instructed not to breastfeed due to the potential for Orthoebolavirus zairense transmission. ( 8.2 )
8.1Pregnancy Risk Summary Orthoebolavirus zairense infection is life-threatening for both the mother and fetus and treatment should not be withheld due to pregnancy (see Clinical Considerations ) . Available data from the PALM trial in which pregnant women with Orthoebolavirus zairense infection were treated with EBANGA demonstrate the high rate of maternal and fetal/neonatal morbidity consistent with published literature regarding the risk associated with underlying maternal Orthoebolavirus zairense infection. These data are insufficient to evaluate for a drug associated risk of major birth defects, miscarriage, or adverse maternal/fetal outcome.
Animal reproduction studies with ansuvimab-zykl have not been conducted. Monoclonal antibodies, such as EBANGA, are transported across the placenta; therefore, EBANGA has the potential to be transferred from the mother to the developing fetus. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Maternal, fetal and neonatal outcomes are poor among pregnant women infected with Orthoebolavirus zairense .
The majority of such pregnancies result in maternal death with miscarriage, stillbirth, or neonatal death. Treatment should not be withheld due to pregnancy.
8.2Lactation Risk Summary The Centers for Disease Control and Prevention recommend that mothers with confirmed Orthoebolavirus zairense not breastfeed their infants to reduce the risk of postnatal transmission of Orthoebolavirus zairense infection. There are no data on the presence of ansuvimab-zykl in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk.
The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to ansuvimab-zykl are unknown.
8.4Pediatric Use The safety and effectiveness of EBANGA for the treatment of infection caused by Orthoebolavirus zairense have been established in pediatric patients from birth to less than 18 years of age. Use of EBANGA for this indication is supported by evidence from a multi-center, open label, randomized controlled trial of EBANGA in adults and pediatric participants that included 54 pediatric participants birth to less than 18 years of age, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection.
Of the total number of participants administered EBANGA in the PALM trial, pediatric participants (1 day to 17 years) accounted for 31% (n=54) of the study population in the PALM trial. The 28-day mortality and safety in adult and pediatric participants treated with EBANGA were similar [see Adverse Reactions (6.1) , and Clinical Studies (14) ] . An additional 78 (31%) pediatric participants from birth to less than 18 years of age received EBANGA in an expanded access program.
8.5Geriatric Use Clinical trials of EBANGA did not include sufficient numbers of participants aged 65 and over to determine whether the safety profile of EBANGA is different in this population compared to younger participants. Of the total number of participants administered EBANGA in the PALM trial, 6 participants (3%) were 65 years or older. The limited clinical experience has not identified differences in responses between the elderly and younger participants.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Orthoebolavirus zairense infection is life-threatening for both the mother and fetus and treatment should not be withheld due to pregnancy (see Clinical Considerations ) . Available data from the PALM trial in which pregnant women with Orthoebolavirus zairense infection were treated with EBANGA demonstrate the high rate of maternal and fetal/neonatal morbidity consistent with published literature regarding the risk associated with underlying maternal Orthoebolavirus zairense infection. These data are insufficient to evaluate for a drug associated risk of major birth defects, miscarriage, or adverse maternal/fetal outcome.
Animal reproduction studies with ansuvimab-zykl have not been conducted. Monoclonal antibodies, such as EBANGA, are transported across the placenta; therefore, EBANGA has the potential to be transferred from the mother to the developing fetus. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Maternal, fetal and neonatal outcomes are poor among pregnant women infected with Orthoebolavirus zairense .
The majority of such pregnancies result in maternal death with miscarriage, stillbirth, or neonatal death. Treatment should not be withheld due to pregnancy.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of EBANGA for the treatment of infection caused by Orthoebolavirus zairense have been established in pediatric patients from birth to less than 18 years of age. Use of EBANGA for this indication is supported by evidence from a multi-center, open label, randomized controlled trial of EBANGA in adults and pediatric participants that included 54 pediatric participants birth to less than 18 years of age, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection.
Of the total number of participants administered EBANGA in the PALM trial, pediatric participants (1 day to 17 years) accounted for 31% (n=54) of the study population in the PALM trial. The 28-day mortality and safety in adult and pediatric participants treated with EBANGA were similar [see Adverse Reactions (6.1) , and Clinical Studies (14) ] . An additional 78 (31%) pediatric participants from birth to less than 18 years of age received EBANGA in an expanded access program.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical trials of EBANGA did not include sufficient numbers of participants aged 65 and over to determine whether the safety profile of EBANGA is different in this population compared to younger participants. Of the total number of participants administered EBANGA in the PALM trial, 6 participants (3%) were 65 years or older. The limited clinical experience has not identified differences in responses between the elderly and younger participants.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Ansuvimab-zykl is a recombinant human monoclonal antibody with antiviral activity against Orthoebolavirus zairense [see Microbiology (12.4) ] .
12.2Pharmacodynamics Ansuvimab-zykl exposure-response relationship and the time course of pharmacodynamic response is unknown.
12.3Pharmacokinetics Limited data from 18 healthy participants 22 to 56 years of age suggests that the pharmacokinetic profile of ansuvimab-zykl is consistent with the profile of other IgG1 monoclonal antibodies. Pharmacokinetic data are not available for Orthoebolavirus zairense infected patients. Specific Populations The effect of age, renal impairment or hepatic impairment on the pharmacokinetics of ansuvimab-zykl is unknown.
12.4Microbiology Mechanism of Action EBANGA (ansuvimab-zykl) is a recombinant, human IgG1κ monoclonal antibody that binds to the glycan cap and inner chalice of the EBOV GP1 subunit. The epitope to which it binds is located within the receptor binding domain of EBOV consisting of amino acids LEIKKPDGS (GP residues 111–119). Ansuvimab-zykl binds EBOV GP without the mucin-like domain with a K D of 0.2 nM at pH 7.4 and 0.6 nM at pH 5.3 as measured by biolayer interferometry.
Ansuvimab-zykl blocks binding of EBOV GP1 to the Neiman Pick cell receptor 1 in host cells (half-maximal effective concentration (EC 50 ) value of 0.09 μg/mL), inhibiting virus entry into the host cell. Ansuvimab-zykl exhibited Fc-mediated Antibody Dependent Cellular Cytotoxicity (ADCC) activity against cells expressing EBOV GP when effector cells were added. Antiviral Activity In a live virus plaque-reduction neutralization assay performed in Vero E6 cells, ansuvimab-zykl neutralized Orthoebolavirus zairense Mayinga with an EC 50 value of 0.06 µg/mL.
In a pseudotyped EBOV GP lentivirus infectivity assay using HEK293 cells, ansuvimab-zykl inhibited Orthoebolavirus zairense Mayinga with an EC 50 value of 0.09 μg/mL and Orthoebolavirus zairense Makona with an EC 50 value of 0.15 μg/mL. The ADCC activity of ansuvimab-zykl was assessed in EBOV GP-transduced and non-transduced HEK293T target cells in the presence of antibody with effector cells added at an effector-to-target cell ratio 1:50 and analyzed via flow cytometry. Ansuvimab-zykl mediated ADCC, with maximal activity observed at mAb concentration of 0.03 μg/mL.
Treatment of Orthoebolavirus zairense infected rhesus macaques with a single IV dose of ansuvimab-zykl (50 mg per kg) generally protected infected animals from Orthoebolavirus zairense mediated death when drug was administered 5 days post-infection. Antiviral Resistance No in-vivo nonclinical or clinical studies specifically evaluating resistance to ansuvimab-zykl have been conducted. The possibility of resistance to ansuvimab-zykl should be considered in patients who either fail to respond to therapy or who develop relapse of disease after an initial period of responsiveness.
Cell Culture Resistance Ansuvimab-zykl cell culture resistance studies have been performed using replication competent recombinant vesicular stomatitis virus expressing the EBOV surface glycoprotein (rVSV-EBOV GP). The rVSV-EBOV GP virus was sequentially sub-cultured in six experiments for up to 5 passages in the presence of a concentration range of ansuvimab-zykl (0.08 to 50 µg/mL) to determine if escape mutants developed via selective pressure. A total of seven different amino acid substitutions in the EBOV GP were found ( Table 4 ).
Three of the seven were detected at less than 1% sequence frequency and were not within the ansuvimab-zykl GP epitope or within 5Å of the epitope, and therefore were excluded from further analysis. Table 4 Identification of Ebola GP Substitutions in Cell Culture Studies a Frequency range of the sequences in 6 replicate experiments identified at the highest ansuvimab-zykl concentration of 50 µg/mL GP Substitutions % Frequency of Sequences with the Substitution a Ansuvimab-zykl Amino Acid Substitutions Sel… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Ansuvimab-zykl is a recombinant human monoclonal antibody with antiviral activity against Orthoebolavirus zairense [see Microbiology (12.4) ] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED / STORAGE AND HANDLING How Supplied EBANGA (ansuvimab-zykl) for injection is supplied as a sterile, preservative-free, off-white to white lyophilized powder in a single-dose vial (NDC 71655-578-01) for reconstitution and further dilution. One primary carton (NDC 71655-578-02) contains thirty-six 400 mg vials packaged in a box containing either one primary carton (NDC 71655-578-03), four primary cartons (NDC 71655-578-04), or eight primary cartons (NDC 71655-578-08). Storage and Handling Store refrigerated at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light.
Do not freeze. Do not shake. Prior to reconstitution, allow EBANGA vial(s) to reach ambient temperature (15°C to 27°C [59°F to 81°F]) for approximately 20 minutes.
If for any reason reconstitution cannot proceed immediately upon reaching ambient temperature, vials that have NOT been reconstituted may be kept at ambient temperature, protected from light, for no more than 24 hours. After reconstitution, if storage is needed, the entire storage time for the reconstituted solution in the vial and the diluted solution in the IV bag should be protected from light and limited to 4 hours refrigerated at 2°C to 8°C (36°F to 46°F) [see Dosage and Administration (2.2) ] .
📦 Storage and Handling ▾
Storage and Handling Store refrigerated at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light. Do not freeze. Do not shake.
Prior to reconstitution, allow EBANGA vial(s) to reach ambient temperature (15°C to 27°C [59°F to 81°F]) for approximately 20 minutes. If for any reason reconstitution cannot proceed immediately upon reaching ambient temperature, vials that have NOT been reconstituted may be kept at ambient temperature, protected from light, for no more than 24 hours. After reconstitution, if storage is needed, the entire storage time for the reconstituted solution in the vial and the diluted solution in the IV bag should be protected from light and limited to 4 hours refrigerated at 2°C to 8°C (36°F to 46°F) [see Dosage and Administration (2.2) ] .
📋 Description ▾
11 DESCRIPTION Ansuvimab-zykl is an Orthoebolavirus zairense (EBOV) glycoprotein 1 (GP1)-directed recombinant, human IgG1 monoclonal antibody. Ansuvimab-zykl is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology and has an approximate molecular weight of 147 kDa. EBANGA (ansuvimab-zykl) for injection is a sterile, preservative-free, off-white to white lyophilized powder in a single-dose vial for IV use after reconstitution and dilution.
Each single-dose vial delivers 400 mg of ansuvimab-zykl, and L-histidine (12.4 mg), L-histidine HCl (16.8 mg), polysorbate 80 (1.6 mg), and sucrose (657 mg). After reconstitution with 7.7 mL of Sterile Water for Injection, USP, each vial delivers 8 mL of a clear and colorless to slightly yellow solution containing 50 mg/mL of ansuvimab-zykl, with an approximate pH of 6.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Hypersensitivity Reactions Including Infusion-Associated Events Inform patients that hypersensitivity reactions including infusion-associated events have been reported during and post-infusion with EBANGA and to immediately report if they experience any symptoms of systemic hypersensitivity reactions [see Warnings and Precautions (5.1) ]. Lactation Instruct patients with Orthoebolavirus zairense not to breastfeed because of the risk of passing Orthoebolavirus zairense to the baby [see Use in Specific Populations (8.2) ].
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Limited data from 18 healthy participants 22 to 56 years of age suggests that the pharmacokinetic profile of ansuvimab-zykl is consistent with the profile of other IgG1 monoclonal antibodies. Pharmacokinetic data are not available for Orthoebolavirus zairense infected patients. Specific Populations The effect of age, renal impairment or hepatic impairment on the pharmacokinetics of ansuvimab-zykl is unknown.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Ansuvimab-zykl exposure-response relationship and the time course of pharmacodynamic response is unknown.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The efficacy of EBANGA has been evaluated in 174 participants with confirmed Orthoebolavirus zairense infection in the PALM trial, a multi-center, open-label, randomized, controlled trial (NCT03719586). The trial was conducted in the North Kivu and Ituri provinces in the Democratic Republic of Congo, where an outbreak began in August 2018, and enrolled 681 participants of all ages, including pregnant women, with documented Orthoebolavirus zairense infection and symptoms of any duration who were receiving oSOC.
Eligible participants had a positive reverse transcriptase-polymerase chain reaction (RT-PCR) for the nucleoprotein (NP) gene of Orthoebolavirus zairense and had not received other investigational treatments (with the exception of experimental vaccines) within the previous 30 days. Neonates ≤7 days of age were eligible if the mother had documented infection. Neonates born to a mother who had cleared Orthoebolavirus zairense following a course of her assigned investigational medication were also eligible to be enrolled at investigator discretion regarding the likelihood that the neonate was infected.
Participants were randomized to receive EBANGA 50 mg/kg IV as a single infusion, an investigational control 50 mg/kg IV every third day, for a total of 3 doses, or other investigational drugs. Randomization was stratified by reverse transcription-PCR cycle threshold calculated using NP targets (CtNP ≤22.0 vs ˃22.0; corresponding to high and low viral load, respectively) and Ebola Treatment Unit (ETU) site. All participants received oSOC consisting, at a minimum, of IV fluids, daily clinical laboratory testing, correction of hypoglycemia and electrolyte imbalances, and broad-spectrum antibiotics and antimalarials, as indicated.
The primary efficacy endpoint was 28-day mortality. The primary analysis population includes all participants who were randomized and concurrently eligible to receive either EBANGA or the investigational control during the same time period of the trial. The demographics and baseline characteristics are provided in Table 6 below.
Table 6 Demographics and Baseline Characteristics in PALM Trial Parameter EBANGA N=174 N (%) Control N=168 N (%) a Pregnancy positive test was calculated based on participants who were pregnant. Denominator for percentages is the number of females in the treatment group. CtNP = cycle threshold calculated using NP targets; IQR=interquartile range; AST=Aspartate aminotransferase; ALT=Alanine aminotransferase; ETU=Ebola treatment unit.
Mean age (years) 27.3
29.9Age <1 month, n (%) 4 (2) 2 (1) Age 1 month to <1 year, n (%) 7 (4) 5 (3) Age 1 year to <6 years, n (%) 15 (9) 12 (7) Age 6 years to <12 years, n (%) 13 (7) 5 (3) Age 12 years to <18 years, n (%) 15 (9) 9 (5) Age 18 years to <50 years, n (%) 93 (53) 114 (68) Age 50 years to <65 years, n (%) 21 (12) 18 (11) Age ≥65 years, n (%) 6 (3) 3 (2) Female, n (%) 98 (56) 87 (52) Positive result on pregnancy test a , n (%) 5/98 (5) 4/87 (5) RT-PCR CtNP cycle threshold ≤22, n (%) 73 (42) 70 (42) Median RT-PCR CtNP (IQR) 23.3 (19.7, 28.5) 23.1 (19.0, 26.5) Median creatinine (IQR) 0.9 (0.6, 2.4) 1.2 (0.8, 4.3) Median AST (IQR) 234 (66, 978) 351 (112, 1404) Median ALT (IQR) 168 (44, 551) 236 (48, 631) Median days from onset of symptoms to randomization (IQR) 5 (3, 7) 5 (3, 7) Reported Vaccination with rVSV-ZEBOV vaccine, n (%) 36 (21) 41 (24) <10 days before ETU admission, n (%) 22/36 (61) 21/41 (51) ≥10 days before ETU admission, n (%) 12/36 (33) 18/41 (44) Timing unknown, n (%) 2/36 (6) 2/41 (5) The PALM trial was stopped early on the basis of a pre-specified interim analysis showing a statistically significant reduction in mortality for EBANGA compared to control assessed at Day 28.
Mortality efficacy results are shown in Table 7 and Figure 1 . Table 7 Mortality Rates in PALM Trial N=Number of participants in the Concurrent Intention-to-Treat population and treatment group; n=Number of participants with the 28-day ou… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, genotoxicity and fertility studies have not been conducted with ansuvimab-zykl.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, genotoxicity and fertility studies have not been conducted with ansuvimab-zykl.
📚 References ▾
15 REFERENCES Rayaprolu V, Fulton BO, Rafique A, Arturo E, Williams D, Hariharan C, Callaway H, Parvate A, Schendel SL, Parekh D, Hui S, Shaffer K, Pascal KE, Wloga E, Giordano S, Negron N, Ni M, Copin R, Atwal GS, Franklin M, Boytz RM, Donahue C, Davey R, Baum A, Kyratsous CA, Saphire EO. Structure of the Inmazeb Cocktail and Resistance to Ebola Virus Escape. Cell Host Microbe. 2023 Feb 8;31(2):260-272.e7. doi: 10.1016/j.chom.2023.01.002.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL – 400 mg vial label NDC 71655-578-01 ebanga ® (ansuvimab-zykl) for Injection 400 mg per vial For Intravenous Use. Reconstitute and dilute prior to administration. Rx Only Recommended Dosage: See prescribing information.
Single-Dose Vial. Discard Unused Portion. Store at 2°C to 8°C (36°F to 46°F).
Protect from light. Do not freeze. Do not shake.
Mfg by: Emergent BioDefense Operations Lansing LLC, Lansing, MI 48906 U.S. Lic. No.
1755 400 mg vial label
PRINCIPAL DISPLAY PANEL – Carton containing 36x400 mg vials NDC 71655-578-02 Rx only ebanga ® (ansuvimab-zykl) For Injection 400 mg per vial For intravenous use Contents: 36 x 400 mg vials Carton containing 36x400 mg vials
PRINCIPAL DISPLAY PANEL – Box containing single carton NDC 71655-578-03 Rx only ebanga ® (ansuvimab-zykl) For injection 400 mg per vial For Intravenous use Contents: 1 x 36 x 400 mg vials Box containing single carton
PRINCIPAL DISPLAY PANEL – Box containing 4 cartons NDC 71655-578-04 Rx only ebanga ® (ansuvimab-zykl) For injection 400 mg per vial For Intravenous use Contents: 4 x 36 x 400 mg vials Box containing 4 cartons
PRINCIPAL DISPLAY PANEL – Box containing 8 cartons NDC 71655-578-08 Rx only ebanga ® (ansuvimab-zykl) For injection 400 mg per vial For Intravenous use Contents: 8 x 36 x 400 mg vials Box containing 8 cartons
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