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Regeneron Covid Medicine Gets Positive Opinion From Europe Panel

A European Medicines Agency committee has recommended approval of its antibody cocktail to treat and prevent Covid.
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Regeneron Pharmaceuticals  (REGN) - Get Regeneron Pharmaceuticals, Inc. Report said that a European Medicines Agency committee recommended approval of its antibody cocktail to treat and prevent Covid-19.

“The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the casirivimab and imdevimab antibody cocktail, known as Regen-Cov in the U.S. and Ronapreve in the European Union and other countries,” Regeneron said.

“The positive opinion is for people aged 12 years and older for the treatment of nonhospitalized patients with confirmed Covid-19 who do not require oxygen supplementation and are at increased risk of progressing to severe Covid-19 and to prevent Covid-19.”

Further, “A final decision from the European Commission regarding approval of the antibody cocktail is expected in the near future,” Regeneron said,

The company’s stock recently traded at $626.16, up 0.6%. It has gained 24% over the past six months.

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The positive opinion is based on two positive Phase 3 trials, Regeneron said. It created the antibody, and Roche  (RHHBY)  is primarily responsible for development and distribution outside the U.S.

“In addition to this marketing authorization application, the companies intend to submit a future Type II Variation to the EMA that seeks to expand the potential indication to include the treatment of patients hospitalized because of Covid-19,” Regeneron said.

In the U.S., Regen-Cov hasn’t been approved by the Food and Drug Administration.

 But it does have emergency-use authorization for some post-exposure prophylaxis settings and as a treatment for non-hospitalized people with mild to moderate Covid-19 who are at high risk of serious consequences.

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