Japan Approves Regeneron's Antibody Cocktail To Treat Mild To Moderate COVID-19

Japan's Ministry of Health, Labour and Welfare has approved Regeneron Pharmaceuticals Inc.'s (REGN) casirivimab and imdevimab antibody cocktail to treat patients with mild to moderate COVID-19.

It marks the first time the antibody cocktail, known as REGEN-COVTM in the U.S. and Ronapreve in other countries, has received a full approval to treat COVID-19, Regeneron said in a statement.

Emergency or temporary pandemic use authorizations are currently in place in more than 20 countries, including in the U.S., European Union, India, Switzerland and Canada.

In Japan, the antibody cocktail was granted a Special Approval Pathway. The approval was based on results from a Phase 3 trial in high-risk non-hospitalized patients, which showed the antibody cocktail reduced the risk of hospitalization or death by 70%, as well as results from a Phase 1 trial that examined the safety, tolerability and pharmacokinetics in Japanese people.

Regeneron invented REGEN-COV and is collaborating with Roche to increase global supply of the antibody cocktail, with Roche primarily responsible for development and distribution outside the U.S.

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