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Regeneron COVID-19 Antibody Poised To Add Prevention Claim, Sub-Q Formula

 
• By Jessica Merrill

The company is requesting FDA expand the antibody cocktail to include a COVID prevention claim with a lower 1,200mg dose and a subcutaneously administered formula.

Vector illustration of monoclonal antibody for coronavirus treatment
Regeneron aims to broaden the reach of its COVID-19 antibody • Source: Alamy (srikijt / Alamy Stock Vector/Alamy Stock Vector)

Regeneron Pharmaceuticals, Inc.’s REGEN-COV (casirivimab/imdevimab) could soon be available for a new expanded indication for COVID-19 prevention in certain populations and in a new subcutaneous formulation that could be easier to administer than the existing intravenous formulation. The company said on 12 April it will share Phase III data in the prevention setting with the US Food and Drug Administration and request expansion of the emergency use authorization (EUA) to include a new claim, while the company has already said it will discuss the new formulation and a lower 1,200mg dose with the agency.

Regeneron's REGEN-COV, along with another antibody from Eli Lilly and Company, is already part of the armamentarium used against...

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