Infectious Disease

The FDA approves one other Ebola remedy

December 23, 2020

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The FDA has approved Ebanga, a human monoclonal antibody developed by Ridgeback Biotherapeutics, for the treatment of the Ebola virus.

The monoclonal antibody, formerly known as mAb114, was declared a breakthrough 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 that found it – along with Regeneron’s monoclonal Outbreak antibody cocktail – to have a beneficial impact on mortality.

Inmazeb Regeneron therapy was the first Ebola treatment to be approved by the FDA in October. Both therapies protect against the Zaire Ebola virus, one of four types known to cause potentially fatal diseases in humans.

Ebanga, Inmazeb, and two other therapies were evaluated in the PALM study during the second largest Ebola outbreak in history. Preliminary results showed that patients receiving Ebanga had an overall mortality rate of 34% compared to 53% for Gildes Sciences Remdesivir, 49% for ZMapp by Mapp Biopharmaceutical, and 29% for Inmazeb.

Ebanga was even more effective in patients with low viral loads, reducing the mortality rate to 11%.

In September Ridgeback CEO Wendy Holman In a statement resulting from the study, the FDA’s decision to classify Ebanga as a breakthrough therapy was “catalyzed”.

The FDA said Ebanga should not be given at the same time as a live virus vaccine for Ebolavirus, as this could inhibit replication of the vaccine virus and potentially reduce the vaccine’s effectiveness. The FDA approved a live attenuated Ebola vaccine last December.

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