FDA Authorizes Regeneron's Covid-19 Antibody Cocktail Drug -- Update
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 Food and Drug Administration 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. Mr. Trump later
attributed his recovery. "They gave me Regeneron, and it was like,
unbelievable. I felt good immediately," he said.
The FDA 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
"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
Earlier this month, the FDA issued an emergency authorization
for an antibody drug made by Eli Lilly & Co. for a similar set
The FDA didn't authorize the treatments for hospitalized
patients. In the sickest patients, those requiring high-flow oxygen
support or mechanical ventilation while hospitalized, monoclonal
antibodies such as Regeneron and Eli Lilly's drugs could make
patients sicker, the FDA warned.
The Eli Lilly and Regeneron drugs are the first to show
promising results in treating patients who haven't yet been
hospitalized, filling a big hole in treatment.
Previous drugs cleared for Covid-19 use, such as Gilead Sciences
Inc.'s remdesivir, were authorized for hospitalized patients.
Lilly and Regeneron were among the first to set out to develop
antibody drugs for Covid-19 after the virus's genetic sequence was
published in January. Other companies working on the therapies
include AstraZeneca PLC, GlaxoSmithKline PLC and Vir Biotechnology
Antibodies are soldiers in the body's immune system that help it
fight off pathogens. Lab-made antibody drugs mimic their natural
Lilly's antibody drug was derived from antibodies isolated from
the blood of a patient who recovered from Covid-19. Regeneron's
drug combines an antibody from a recovered patient and one
generated by mice with genetically modified immune systems.
The drugs are made from living cells, a process that is more
complicated and expensive than making pills. Both companies say
shortages are likely given the expected demand.
Regeneron has agreed to provide the first 300,000 doses to the
U.S. government as part of a $450 million contract signed in
Regeneron said it would have enough doses of its drug to treat
80,000 patients by the end of November, an additional 120,000 doses
in the first week of January, and another 100,000 doses by the end
of January 2021.
The drug cocktail contains antibodies named casirivimab and
imdevimab, a combination that formerly went by the code name
"Demand may exceed supply initially, making it even more
critical that federal and state governments ensure REGEN-COV2 is
distributed fairly and equitably to the patients most in need,"
Regeneron Chief Executive Leonard Schleifer said in a
An FDA fact sheet on the drug says it may be ineffective against
strains of the coronavirus that are resistant to the
"We are encouraged that no variants resistant to the cocktail
were identified in the clinical trial analyses to date, which is
consistent with our preclinical findings," Regeneron Chief
Scientific Officer George D. Yancopoulos said in a statement.
Write to Joseph Walker at firstname.lastname@example.org
(END) Dow Jones Newswires
November 21, 2020 21:26 ET (02:26 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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