RHHBY Roche Holdings Ltd AG (QX)

By Colin Kellaher

Regeneron Pharmaceuticals Inc. on Thursday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of its antibody cocktail to treat and prevent Covid-19.

The Tarrytown, N.Y., biotechnology company said the CHMP's positive opinion covers the drug for the treatment of non-hospitalized Covid-19 patients ages 12 and up who don't need supplemental oxygen who are at increased risk of progressing to severe Covid-19, and for the prevention of the disease.

Regeneron invented the antibody cocktail, known as REGEN-COV in the U.S. and Ronapreve elsewhere around the world, and is collaborating with Swiss pharmaceutical company Roche Holding AG, which is primarily responsible for development and distribution outside the U.S.

Regeneron said it expects a decision from the European Commission, which generally follows the CHMP's advice, in the near future.

The U.S. Food and Drug Administration previously granted emergency-use authorization for REGEN-COV in certain post-exposure preventative settings and as a treatment for non-hospitalized patients with mild to moderate Covid-19 who are at high risk of serious consequences from the disease.

The agency last month granted priority review to Regeneron's application for full approval of the drug for non-hospitalized patients. Regeneron said it expects to complete an FDA submission focusing on hospitalized patients by the end of the year.

Regeneron earlier this week said a long-term study showed REGEN-COV continued to provide strong protection against Covid-19 infection for eight months, reducing the risk of contracting the disease by 81.6% compared with a placebo.

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

(END) Dow Jones Newswires

November 11, 2021 11:42 ET (16:42 GMT)

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