Regeneron drug prevents symptomatic Covid-19 by 81% - Insights from The Wall Street Journal

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.

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

Appeared in the April 12, 2021, print edition as 'Regeneron Drug Curbs Risk of Infection.'

Regeneron drug prevents symptomatic Covid-19 by 81% – With insights from The Wall Street Journal

Covid-19 Drug Prevents Symptomatic Disease in Study, Regeneron Says

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