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# Regeneron Seeks Approval for Covid Therapy
- URL: https://www.fdaweb.com/regeneron-seeks-approval-for-covid-therapy/
- Published: 2021-10-14T12:00:00.000Z
- Updated: 2026-09-14T17:19:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150367

FDA has accepted for priority review a Regeneron Pharmaceuticals BLA for Regen-Cov (casirivimab and imdevimab) for treating Covid-19 in non-hospitalized patients and as prophylaxis in certain individuals. Currently, the therapy is [authorized](https://c212.net/c/link/?t=0&l=en&o=3323077-1&h=1377434215&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3248768-1%26h%3D3509491638%26u%3Dhttps%253A%252F%252Fwww.regeneron.com%252Fdownloads%252Ftreatment-covid19-eua-fact-sheet-for-hcp.pdf%26a%3Dauthorized&a=authorized&ref=fdaweb.com) under an emergency use authorization to treat people with mild to moderate Covid-19 who are at high risk of serious consequences from Covid-19 infection who are either already infected (non-hospitalized) or in certain post-exposure prophylaxis settings. The agency has set a 4/13/2022 review action target date.

The submission is supported by two positive Phase 3 trials involving more than 6,000 patients that evaluated the efficacy and safety of REGEN-COV in the patient populations, according to the company. A second BLA submission for treating patients hospitalized due to Covid-19 is expected to be submitted later this year.