Regeneron Pharmaceuticals received Priority Review by the U.S. FDA for a new Biologics License Application (BLA) for REGN-EB3, an investigational triple antibody cocktail treatment for Ebola virus infection. The target action date for the FDA decision is October 25, 2020.

The REGN-EB3 BLA is supported by data from the randomized, controlled PALM clinical trial demonstrating superior efficacy compared to the control arm across multiple measures, including reduced mortality and fewer days until the Ebola virus was no longer detected in the bloodstream.

Regeneron’s VelociSuite technologies enable the creation and selection of potent fully-human antibodies against a specific biological target, which is particularly critical for addressing new and/or quickly-spreading pathogens such as Ebola and COVID-19. These technologies facilitate the rapid cloning and generation of optimized fully-human antibodies from both VelocImmune mice and convalescing human volunteers, and allow for the rapid escalation of fully-human antibodies into manufacturing-quality cell line production and large-scale bioreactor manufacturing. Once strong therapeutic antibody candidates are identified, the company’s in-house preclinical, clinical and commercial-scale manufacturing capabilities allow for fast scale-up to adapt to current need.

REGN-EB3 has received Orphan Drug and Breakthrough Therapy designation from the FDA. It is being developed under an ongoing collaboration and with funding provided by the Biomedical Advanced Research and Development Authority (BARDA).