Covid-19 Drug Prevents Symptomatic Disease in Study, Regeneron Says
April 12 2021 - 4:48AM
Dow Jones News
By Joseph Walker
An antibody drug from Regeneron Pharmaceuticals Inc. reduced the
risk of developing symptomatic Covid-19 infection by 81% compared
with a placebo in people living with someone infected by the new
coronavirus, a study found.
The results point to potential new preventive applications for
the drug, which is already in use to treat earlier Covid-19
cases.
Regeneron said Monday it would ask the U.S. Food and Drug
Administration to expand the drug's authorization among people
exposed to the virus who haven't yet been vaccinated, which could
provide temporary stopgap protection as people await vaccines.
So far, 21.3% of the U.S. population has been fully vaccinated,
and 35.3% has received at least one shot.
"With more than 60,000 Americans continuing to be diagnosed with
Covid-19 every day, the REGEN-COV antibody cocktail may help
provide immediate protection to unvaccinated people who are exposed
to the virus, " said George D. Yancopoulos, Regeneron's president
and chief scientific officer.
Regeneron issued the Phase 3 data in a press release, and the
findings haven't yet been published in a peer-reviewed scientific
journal.
The study was jointly conducted by Regeneron and the National
Institute of Allergy and Infectious Diseases and includes fuller
results than interim findings the company released in January.
REGEN-COV is currently authorized to treat people infected with
Covid-19 who have mild to moderate symptoms and are at high risk of
developing severe disease because of factors including age or
underlying conditions such as obesity.
In studies, the drug reduced the risk of hospitalization or
death by about 70%.
The newest prevention study enrolled about 1,500 people living
with someone recently diagnosed with Covid-19. They were randomly
assigned to receive shots of the Regeneron drug or a placebo.
After one month, 1.5% of volunteers receiving REGEN-COV had
symptomatic Covid-19 infections, compared with 7.8% of those who
received a placebo, amounting to an 81% risk reduction, Regeneron
said.
There weren't any hospitalizations or emergency-room visits
stemming from Covid-19 among volunteers taking Regeneron's drug,
compared with four volunteers in the placebo group, according to
the company.
The antibody drug also appeared to help speed recovery among
those who contracted Covid-19 symptoms. Volunteers who received the
drug had symptoms for an average of 1.2 weeks, compared with an
average of 3.2 weeks in the placebo group, the company said.
Regeneron didn't disclose how many volunteers tested positive
for Covid-19 without showing symptoms but plans to in the future, a
company spokeswoman said.
REGEN-COV is a cocktail of two monoclonal antibodies, molecules
that mimic the antibodies naturally produced by the immune system
to fight viruses and bacteria.
The FDA first cleared use of the drug in November under an
emergency-use authorization, which a medication to be prescribed
before it has completed the complete battery of testing required
for a full approval.
The drug gained attention last October, after it was given to
then-President Trump, who then praised the therapy's impact.
Yet REGEN-COV and a rival antibody drug made by Eli Lilly &
Co. haven't been used as much health officials had expected, partly
because they are given by intravenous infusion, which can be
cumbersome for hospitals to administer.
In Regeneron's prevention study, volunteers were given the drug
with simpler-to-use subcutaneous shots in which the drug is
injected through the skin.
"Convenient subcutaneous administration of REGEN-COV could help
control outbreaks in high-risk settings where individuals have not
yet been vaccinated, including individual households and group
living settings," said Myron Cohen, director of the Institute for
Global Health and Infectious Diseases at the University of North
Carolina at Chapel Hill. He helped lead the study on behalf of
NIAID.
Write to Joseph Walker at joseph.walker@wsj.com
(END) Dow Jones Newswires
April 12, 2021 04:33 ET (08:33 GMT)
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