Regeneron Set to Request FDA Approval to Use Covid Antibody Drug as a Preventative Treatment

Regeneron Set to Request FDA Approval to Use Covid Antibody Drug as a Preventative Treatment

Regeneron Pharmaceuticals (NASDAQ: REGN) announced Monday that it is prepared to ask the Food and Drug Administration for approval to use its Covid-19 antibody therapy as a preventative treatment. In its most recent study, the treatment, known as REGEN-COV revealed that with a dose of 1,200 mg administered subcutaneously reduced the risk of symptomatic infections by 81% in individuals that were not infected when they began the trial.

“These data suggest that REGEN-COV can complement widespread vaccination strategies, particularly for those at high risk of infection. Importantly, to date REGEN-COV has been shown in vitro to retain its potency against emerging COVID-19 variants of concern,” said Myron Cohen, M.D., who leads the monoclonal antibody efforts for the NIH-sponsored COVID Prevention Network (CoVPN) and is Director of the Institute for Global Health & Infectious Diseases at the University of North Carolina at Chapel Hill.

The company also confirmed that people who were symptomatic and were then given the drug resolved their symptoms, on average, two weeks faster than those who were administered a placebo.

“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,” Dr. George Yancopoulos, president and chief scientific officer at Regeneron, said in a press release.

The trial consisted of 1,501 people that were not infected with COVID-19 but shared the same household as someone that recently tested positive for the virus. People in the trial received either a dose of REGEN-COV or a placebo.

Experts say that treatments for the virus are critical in putting an end to the ongoing pandemic that has already killed approximately 561,800 Americans.

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