The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for REGN-EB3 for the treatment of Ebola virus infection.
REGN-EB3 is a triple-antibody cocktail that utilizes the Company’s proprietary VelocImmune® platform. The platform uses a mouse model with a genetically humanized immune system and associated VelociSuite® technologies to generate multiple fully-human antibodies against targets such as Ebola and COVID-19.
The BLA is supported by data from the randomized, controlled phase 2/3 PALM trial that compared the efficacy and safety of REGN-EB3, mAb114, and remdesivir to the control arm, ZMapp, in addition to optimized standard of care. The trial included 681 patients who had Ebola during the ongoing outbreak in the Democratic Republic of the Congo. In August 2019, the trial was stopped early due to preliminary data that showed REGN-EB3 to be superior to ZMapp.
Findings from the study showed that REGN-EB3 crossed the pre-specified superiority threshold for preventing death (primary end point) at day 28 compared with ZMapp (mortality at 28 days: 33.5% vs 51.3%, respectively; P =.002). Additionally, REGN-EB3 showed superior efficacy for reducing the number of days until the Ebola virus was no longer detected in the bloodstream (secondary end point) compared with ZMapp.
The FDA previously granted Orphan Drug and Breakthrough Therapy designations to REGN-EB3 for this indication. A Prescription Drug User Fee Act (PDUFA) target date of October 25, 2020 has been set for the application.
The Company is also utilizing its VelociSuite technologies to develop a treatment for COVID-19 and expects to begin initial clinical trials in June.
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