EBANGA (ansuvimab-zykl) · RIDGEBACK BIOTHERAPEUTICS
EBANGA (ansuvimab-zykl) is a human monoclonal antibody indicated for the treatment of infection caused by Zaire ebolavirus. The therapy is approved for use in adult and pediatric populations, including neonates born to mothers who have tested positive for the virus via RT-PCR. Its clinical application is specific to the Zaire species, as efficacy has not been established for other species of the Ebolavirus or Marburgvirus genera. Healthcare providers are advised to consider current drug susceptibility patterns when initiating treatment, as viral resistance or changes in virulence may impact the drug's effectiveness.
How EBANGA Works
Ansuvimab-zykl is a recombinant human monoclonal antibody that exerts antiviral activity against the Zaire ebolavirus. The drug specifically targets the Zaire ebolavirus glycoprotein (EBOV GP) to combat the infection. By binding to this biological target, the antibody works to inhibit the virus within the patient. The effectiveness of this mechanism is dependent on the specific viral strain, as mutations or emergence of resistance can diminish the antibody's clinical benefit.
Details
- Status
- Prescription
- First Approved
- 2020-12-21
- Patent Cliff
- 2027
- Routes
- IV (INFUSION)
- Dosage Forms
- POWDER
EBANGA Approval History
What EBANGA Treats
1 indicationsEBANGA is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Zaire Ebola Virus Infection
EBANGA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EBANGA FDA Label Details
Indications & Usage
FDA Label (PDF)EBANGA is indicated for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection [see Dosage and Administration and Clinical Studies ] . EBANGA™ (ansuvimab-zykl) is a Zaire ebolavirus glycoprotein (EBOV GP)-directed human monoclonal antibody indicated for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection. Limitation of Use The efficacy of EBANGA has n...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.