FDA Extends Review of Regeneron's REGEN-COV Covid-19 Drug
14 April 2022 - 9:53PM
Dow Jones News
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
April 14, 2022 07:38 ET (11:38 GMT)
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