Regeneron (REGN) announces EMA Issues Advice on its Antibody Cocktail (casirivimab with imdevimab) for Certain COVID-19 Patients

February 26, 2021 6:47 AM EST

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EU member states can utilize the positive CHMP opinion when making national decisions about use of the antibody cocktail, prior to a potential future EMA market authorization

Regeneron has collaborated with Roche to develop and manufacture the antibody cocktail; Roche is responsible ex-U.S. and has already begun distribution in the EU

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the company's investigational COVID-19 antibody cocktail (casirivimab with imdevimab). The CHMP recommends that the antibody cocktail, known as REGEN-COVTM in the U.S., can be used to treat confirmed COVID-19 in patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.

"Today's endorsement by the EU's leading scientific body for medicines helps bring our antibody cocktail one step closer to even more COVID-19 patients who could benefit from it," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "Our collaborator Roche is already in active discussions with a number of European countries following release of our data in non-hospitalized patients that showed the antibody cocktail significantly reduced virus levels within days of treatment, which was associated with significantly fewer medical visits. This is supported by preclinical data that show that our antibody cocktail effectively neutralizes emerging strains of the virus, which are becoming increasingly common in Europe and around the world."

The CHMP recommendation provides a harmonized, European Union (EU)-level opinion on the efficacy, quality and safety of the antibody cocktail, which can be used by EU member states when making decisions on the possible use of the antibody cocktail at a national level prior to a market authorization. Under Article 5(3) of Regulation EC 726/2004, the CHMP assessed available data in non-hospitalized patients ("outpatients") with COVID-19 as well as supportive data from other settings.

The CHMP's review took place in parallel to the EMA's ongoing rolling review process, which is used to speed up the formal marketing application assessment of a promising medicine during a public health emergency. Once finalized it will be the basis for an EU marketing authorization for the antibody cocktail. Regeneron, together with Roche, continues to work closely with the EMA as it undertakes its rolling review.

Regeneron is collaborating with Roche to increase global supply of the antibody cocktail. Regeneron is responsible for development and distribution of the treatment in the U.S., and Roche is primarily responsible for development and distribution outside the U.S., with the first Roche-manufactured doses already being distributed. The companies share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.

The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.

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