By Colin Kellaher


Regeneron Pharmaceuticals Inc. on Thursday said the U.S. Food and Drug Administration has extended by three months its review of the company's application seeking formal approval of its REGEN-COV monoclonal antibody drug for Covid-19.

The Tarrytown, N.Y., biotechnology company, which is seeking approval of REGEN-COV to treat non-hospitalized Covid-19 patients and for prevention of the illness in certain individuals, said the extension is due to ongoing talks with the FDA on pre-exposure preventative use.

Regeneron said it submitted additional data from its completed prophylaxis trial, which the FDA deemed to be a major amendment to the application, leading to the extension.

Regeneron said the FDA set a new target action date of July 13, adding that the agency hasn't requested any new studies.

The FDA granted emergency-use authorization to REGEN-COV in November 2020 to treat mild to moderate Covid-19 symptoms in people who are at high risk of developing severe cases.

However, the agency in January restricted the use of REGEN-COV and Eli Lilly & Co.'s bamlanivimab and etesevimab after determining they were unlikely to be effective against the Omicron variant. As a result, REGEN-COV isn't currently authorized for use in any U.S. states, territories or jurisdictions.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

04-14-22 0738ET