FDA approves Ebanga for Zaire ebolavirus treatment (fda.gov)

• Ebanga is a human monoclonal antibody targeting Zaire ebolavirus
• Approval based on PALM trial showing 28-day mortality 35.1% vs 49.4% control
• Administered as single 50 mg/kg IV infusion in adults and children
• FDA granted Orphan Drug and Breakthrough Therapy designations
• Manufacturer: Ridgeback Biotherapeutics, LP

"The FDA has approved Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for the treatment of Zaire ebolavirus infection in adults and children. Approval was based on the PALM trial conducted during the 2018-2019 Ebola outbreak in the Democratic Republic of the Congo, which showed 28-day mortality of 35.1% for Ebanga versus 49.4% for control. Ebanga blocks viral entry into cells. Common side effects include fever, tachycardia, diarrhea, vomiting, hypotension, tachypnea, and chills. Concurrent administration of a live Ebola vaccine should be avoided. Ebanga received Orphan Drug and Breakthrough Therapy designations."