FDA Gives Regeneron’s Ebola Treatment Priority Review

The FDA has granted Regeneron’s investigational Ebola treatment RENG-EB3 a priority review.

The company’s biologics license application (BLA) is supported by data from a clinical trial in the Democratic Republic of Congo that showed superior efficacy compared to Mapp Biopharmaceuticals’ experimental drug ZMapp, including reduced mortality and fewer days until the Ebola virus was no longer detected in the bloodstream.

REGN-EB3 previously received orphan drug and breakthrough therapy designations from the FDA. The agency’s decision date on the BLA is Oct. 25.