FDA approves another Ebola treatment
The FDA has approved Ebanga, a human monoclonal antibody developed by Ridgeback Biotherapeutics, for the treatment of Ebola virus.
The monoclonal antibody, which was formerly known as mAb114, was granted breakthrough status by the FDA in September 2019.
It was isolated from a survivor of the 1995 Ebola outbreak in Kikwit, Democratic Republic of the Congo (DRC), and then included in a landmark randomized controlled trial during a recent large outbreak in the DRC, where it was found — along with Regeneron’s monoclonal antibody cocktail — to have a favorable impact on mortality.
The Regeneron therapy, Inmazeb, became the first FDA-approved Ebola treatment in October. Both therapies protect against Zaire ebolavirus, one of four species known to cause potentially fatal illness in humans.
Ebanga, Inmazeb and two other therapies were evaluated in the PALM trial during the second-largest Ebola outbreak in history. Preliminary findings showed that patients receiving Ebanga had an overall mortality rate of 34%, compared with 53% for Gilead Sciences’ remdesivir, 49% for Mapp Biopharmaceutical’s ZMapp and 29% for Inmazeb.
In patients with low viral loads, Ebanga was even more effective, reducing the mortality rate to 11%.
In September, Ridgeback CEO Wendy Holman said in a statement that results from the trial “catalyzed” the FDA’s decision to classify Ebanga as a breakthrough therapy.
The FDA said Ebanga should not be administered concurrently with a live virus vaccine against Ebolavirus because it could inhibit replication of the vaccine virus and possibly reduce the efficacy of the vaccine. The FDA approved a live, attenuated Ebola vaccine last December.
- FDA. FDA approves treatment for Ebola virus. https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-treatment-ebola-virus. Accessed December 22, 2020.