> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Regeneron Priority Review for Ebola Therapy
- URL: https://www.fdaweb.com/regeneron-priority-review-for-ebola-therapy/
- Published: 2020-04-16T12:00:00.000Z
- Updated: 2026-09-14T16:11:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146589

FDA has accepted for priority review a Regeneron Pharmaceuticals BLA for REGN-EB3, an investigational triple antibody cocktail treatment for Ebola virus infection. The agency has set a user fee review action target date of 10/25\. The submission is supported by data from the randomized, controlled PALM clinical trial conducted in the Democratic Republic of Congo. In 8/2019, the trial was stopped early when preliminary results showed that REGN-EB3 “crossed the pre-specified superiority threshold for preventing death compared to the control arm, ZMapp,” the company says. “REGN-EB3 [demonstrated superior efficacy](https://c212.net/c/link/?t=0&l=en&o=2778543-1&h=2078433846&u=https%3A%2F%2Fnewsroom.regeneron.com%2Fnews-releases%2Fnews-release-details%2Fnew-england-journal-medicine-publishes-results-ebola-clinical&a=demonstrated+superior+efficacy&mod=article%5Finline&ref=fdaweb.com) compared to ZMapp across multiple measures, including reduced mortality and fewer days until the Ebola virus was no longer detected in the bloodstream.”

The therapy was developed using Regeneron’s proprietary VelociSuite rapid response technologies, and the company says it is now applying the same approach to develop an antibody medicine that can potentially prevent and treat Covid-19, with initial clinical trials expected to begin in June. The technologies allow “rapid cloning and generation of optimized fully-human antibodies from both VelocImmune mice (which are genetically-engineered to have genetically-humanized immune systems) 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,” it says.