View of Regeneron Pharmaceuticals’ corporate and research and development headquarters on Old Saw Mill River Road in Tarrytown, New York.
Lev Radin | LightRocket | Getty Images
Regeneron Pharmaceuticals said Monday it will ask the Food and Drug Administration to allow the use of its Covid-19 antibody therapy as a preventative treatment.
The therapy, which was administered to former President Donald Trump shortly after he was diagnosed with Covid-19 last year, has already been authorized by the FDA to treat adults with mild to moderate Covid-19 and pediatric patients at least 12 years of age who tested positive for the virus and have an increased risk of severe disease.
Regeneron said it was trying to expand the use of its treatment in the US after a third-phase clinical study, conducted jointly by the National Institutes of Health, found that the drug reduced the risk of symptomatic infections in individuals by 81%.
The company also said that people who were symptomatic and treated with the drug resolved their symptoms, on average, two weeks faster than those who received a placebo.
“With more than 60,000 Americans continuing to be diagnosed with COVID-19 every day, the REGEN-VOC antibody cocktail can help ensure immediate protection for unvaccinated people who are exposed to the virus,” said Dr. George Yancopoulos, President and CEO. chief at Regeneron, said in a press release.
The trial enrolled 1,505 people who were not infected with the virus but lived in the same household as someone who recently tested positive. Participants received either a dose of Regeneron therapy or a placebo.
The company said 41% of the people in the lawsuit were Hispanic and 9% were black. In addition, 33% of participants were obese and 38% were aged 50 and over, according to the company.
Regeneron therapy is part of a class of treatments known as monoclonal antibodies, which are made to act as immune cells and fight infections. Monoclonal antibody treatments have gained widespread attention following the news that Trump received Regeneron in October.
In recent months, public health officials have become concerned that emerging, highly contagious variants of coronavirus could threaten existing monoclonal antibodies on the market. But Dr. Myron Cohen, who is leading monoclonal antibody efforts for the NIH-sponsored COVID prevention network, said the drug has been shown to retain potency against new strains.
While the world’s attention has turned to the administration of Covid-19 vaccines, health experts say treatments are also extremely important to end the pandemic, which has infected more than 31.1 million Americans and killed at least 561,800. in just over a year, according to data compiled by Johns Hopkins University.