Regeneron's Ebola Drug REGN-EB3 Granted FDA Priority Review

On the morning of April 16 local time, Regeneron announced that the U.S. Food and Drug Administration (FDA) had accepted its application and granted priority review for the Ebola drug REGN-EB3. In clinical trials, REGN-EB3 demonstrated superior therapeutic efficacy compared to ZMapp.

REGN-EB3 is a cocktail of three monoclonal antibodies that previously received orphan drug designation and breakthrough therapy designation.

FDA Approval Will Provide More Effective New Drugs for Ebola Patients Based on Clinical Trial Data. In the clinical trials, 33.5% of patients treated with REGN-EB3 died within 28 days, compared to a mortality rate of 51.3% in the ZMapp control group. Among patients who received REGN-EB3 treatment early in the course of the disease, the mortality rate was 10%.

Remdesivir, which has recently attracted significant attention, was originally developed for the treatment of Ebola. Regeneron’s progress in developing therapeutics for COVID-19 has been relatively slow, with clinical trials scheduled to begin in June; however, its antibodies have demonstrated a higher success rate than remdesivir. The development of these COVID-19 antibodies leverages the same platform used for REGN-EB3, thereby benefiting from Regeneron’s extensive experience in using antibodies to neutralize various viruses, including the Ebola virus.

Responsible Editor: Squirtle

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