Regeneron Reports the US FDA’s Acceptance of Priority Review for REGN-EB3’s BLA to Treat Ebola

Shots:

• The BLA is supported by PALM clinical study conducted in the Democratic Republic of Congo. In Aug’2019, the trial was stopped early when preliminary results demonstrated that REGN-EB showed superiority over ZMapp
• REGN-EB3 demonstrated superior efficacy as compared to ZMapp across multiple measures, including reduced mortality and fewer days until the Ebola virus was no longer detected in the bloodstream
• REGN-EB3 is being developed under an ongoing collaboration with BARDA by utilizing VelociSuite technology and has received the US FDA’s ODD & BT designation with its anticipated PDUFA date as Oct 25, 2020. Regeneron is now utilizing VelociSuite technology to treat COVID-19 with the expected initiation of the clinical trial in June

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