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Regeneron-Roche Covid Antibody Cocktail Recommended for EU

Regeneron-Roche Antibody Cocktail Gets Europe Recommendation

Roche Holding AG and Regeneron Pharmaceuticals Inc.’s antibody cocktail was recommended the European Medicines Agency for authorization as a treatment for Covid-19.

That paves the way for broader use of Ronapreve, the drug combination, in the European Union. The drugmakers already have approval for it in the U.S., and some EU patients had access under an early use program while the regulator was conducting its review. 

While antibody treatments have shown some effectiveness in treating Covid, attention lately has focused on new antiviral pills from Merck & Co. and Pfizer Inc. The pills are easy to take, while the antibody cocktail must be either injected under the skin or infused into a vein. 

Production capacity for the antibody cocktail is also limited. Roche has already sold this year’s supply, Chief Executive Officer Severin Schwan said last month. The EU has a contract to buy 55,000 doses of Ronapreve. The combination can be used for treatment and prevention of Covid in people ages 12 and older weighing at least 40 kilograms (88 pounds), the EMA said.

Separately, the EMA recommended another antibody medicine, Regkirona, for treating adults with Covid who don’t require supplemental oxygen while being at increased risk of the disease becoming severe. That drug is made by Celltrion Inc. of South Korea.

©2021 Bloomberg L.P.