FDA Authorizes Regeneron's Covid-19 Antibody Cocktail Drug
November 21 2020 - 7:42PM
Dow Jones News
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 joseph.walker@wsj.com
(END) Dow Jones Newswires
November 21, 2020 20:27 ET (01:27 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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