FDA Authorizes Regeneron's Covid-19 Antibody Cocktail Drug

By Joseph Walker 

Regeneron Pharmaceuticals Inc.'s Covid-19 antibody drug was authorized Saturday by U.S. health regulators, the second cleared this month to treat patients who aren't hospitalized but are at high risk of developing severe disease.

The FDA cleared the antibody drug cocktail for use treating mild to moderate Covid-19 patients 12 years of age and older, including people older than 65 years.

Regeneron's drug combines two lab-made antibodies designed to latch onto the novel coronavirus and prevent it from replicating and hijacking human cells. The treatment is still being tested in clinical trials, after being developed by Regeneron scientists in Tarrytown, N.Y., earlier this year.

In October, it was one of three pharmaceutical treatments given to President Trump for treatment of Covid-19, and which Mr. Trump later attributed his recovery. "They gave me Regeneron, and it was like, unbelievable. I felt good immediately," he said.

The U.S. Food and Drug Administration said it authorized the drug's emergency use, a kind of clearance the agency has been using during the pandemic to speed up access to medicines.

The FDA said its authorization was based on a study of about 800 people. In the study, 3% of subjects taking Regeneron's drug and who were at high risk of severe disease had to be hospitalized or visit emergency rooms, compared with 9% of patients who received a placebo.

"The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic," Patrizia Cavazzoni, M.D., acting director of the FDA's Center for Drug Evaluation and Research, said in a statement.

Earlier this month, the FDA issued an emergency authorization for antibody drug made by Eli Lilly & Co. for a similar set of patients.

Write to Joseph Walker at [e-mail]

(END) Dow Jones Newswires

November 21, 2020 20:27 ET (01:27 GMT)

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