The Food and Drug Administration (FDA) has approved Ebanga (ansuvimab-zykl; Ridgeback Biotherapeutics) for the treatment of Zaire ebolavirus (Ebola virus) infection in adults and children.
Ebanga is a human IgG1 monoclonal antibody designed to block the binding of the virus to the cell receptor, preventing its entry into the cell. The drug was isolated from a human survivor of the 1995 Ebola virus outbreak in the Democratic Republic of the Congo (DRC) who retained antibodies 11 years after infection.
The approval was based on data from the open-label, controlled phase 2/3 PALM trial, which included 342 participants with confirmed Ebola virus during the outbreak in the DRC during 2018-2019. Patients were randomized to receive a single intravenous infusion of Ebanga 50mg/kg (n=174) or an investigational control (n=168). The primary end point was 28-day mortality.
Results showed that 35.1% of patients treated with Ebanga died after 28 days compared with 49.4% of patients treated with control. The most common adverse reactions noted while receiving Ebanga included fever, tachycardia, diarrhea, vomiting, hypotension, tachypnea, and chills; hypersensitivity reactions were also reported.
“Ansuvimab is a vital tool in the global health armamentarium that will help to keep Ebola in check and stop local epidemics from becoming global pandemics,” said Wendy Holman, CEO and co-founder of Ridgeback. “This powerful experimental treatment has demonstrated an impressive survival benefit in Ebola patients and will supply much needed help to the patients and communities who battle Ebola.”
The FDA previously granted Orphan Drug, Breakthrough Therapy, and Priority Review designations to Ebanga for the treatment of Ebola virus.
- FDA approves treatment for Ebola virus. [press release]. Silver Spring, MD: U.S. Food and Drug Administration; December 21, 2020.
- Ridgeback Biotherapeutics LP announces Priority Review of Biologics License Application for ansuvimab Ebola treatment. [press release]. Miami, FL: Ridgeback Biotherapeutics LP; July 29, 2020.