Regeneron Cocktail Gets FDA Priority Review for Covid-19 Treatment, Prevention

By Colin Kellaher

Regeneron Pharmaceuticals Inc. on Thursday said the U.S. Food and Drug Administration granted priority review to its application for its REGEN-COV antibody cocktail for the treatment and prevention of Covid-19.

The Tarrytown, N.Y., biotechnology company said the application covers the cocktail as a treatment of Covid-19 in non-hospitalized patients and as prophylaxis in some individuals.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.

Regeneron said the FDA set a target action date of April 13, 2022, and that the agency plans to hold an advisory committee meeting to discuss the application.

Regeneron said its application is supported by a pair of Phase 3 studies involving more than 6,000 patients that evaluated the efficacy and safety of REGEN-COV to treat non-hospitalized Covid-19 patients and to prevent symptomatic infection in asymptomatic household contacts of infected individuals.

The company said it expects to file another application focusing on the treatment of hospitalized patients later this year.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

October 14, 2021 07:57 ET (11:57 GMT)

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