Regeneron Releases Positive Trial Data For Covid Antibody Treatment As It Seeks Emergency FDA Authorization

Regeneron Releases Positive Trial Data For Covid Antibody Treatment As It Seeks Emergency FDA Authorization

Regeneron released positive clinical trial data on Wednesday for its monoclonal antibody cocktail, which was used to treat President Donald Trump for Covid-19, as the company seeks emergency use authorization for the drug from the U.S. Food and Drug Administration.

View of Corporate and Research and Development Headquarters...
View of Corporate and Research and Development Headquarters of Regeneron Pharmaceuticals, Inc. PHOTO BY LEV RADIN/PACIFIC PRESS/LIGHTROCKET VIA GETTY IMAGES

KEY FACTS

Data from 524 patients in a randomized, double-blind trial showed Regeneron’s antibody treatment, REGN-COV2, “significantly reduced viral load and patient medical visits,” Regeneron said. 

Including results from a separate batch of 275 patients in the same trial, Regeneron found REGN-COV2 reduced Covid-19 related medical visits by 57% through day 29 of treatment.

The strong effects were recorded in patients with “poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors,” George D. Yancopoulos, Regeneron’s chief scientific officer, said in a statement.

Though it was used by Trump, the treatment isn’t available to the public because it hasn’t yet been given emergency use authorization from the FDA. 

Regeneron said it submitted the data to the FDA, which is reviewing its EUA application.

Regeneron shares jumped 2.9% in after hours trading following the news.

KEY BACKGROUND

Trump credited Regeneron’s antibody cocktail for helping him overcome Covid-19 and promised it would be free for all Americans. He has not elaborated on how he plans to do so. The president was able to get the experimental treatment through a “compassionate use request,” which is only approved for “rare, exceptional circumstances on a case-by-case basis,” Regeneron said.

WHAT TO WATCH FOR

Regeneron has previously said it only has 50,000 doses available, so it’s unclear if the company can boost production before it receives an EUA.

TANGENT

Trump was also treated with Gilead Sciences’ remdesivir, which was given full FDA approval last week despite mixed clinical data about its effectiveness. 

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