View of Regeneron Pharmaceuticals Headquarters Corporate and Research and Development at 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 its Covid-19 antibody treatment to be used as a preventative treatment.
The therapy, which was given 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. age who have tested positive for the virus and are at high risk for serious diseases.
Regeneron said he wanted to expand the use of his treatment in the US after a phase three clinical trial, conducted jointly by the National Institutes of Health, found that the drug reduced the risk of symptomatic infections in individuals by 81% has.
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 still being diagnosed with COVID-19 every day, the RAIN-COV antibody cocktail could help provide immediate protection to unvaccinated people exposed to the virus,” said Dr. George Yancopoulos, president and chief scientific officer at Regeneron, said in a press release.
The trial included 1,505 people who were not infected with the virus but lived in the same household with someone who recently tested positive. Participants received one dose of Regeneron’s treatment or a placebo.
According to the company, 41% of the people in the trial are Spanish and 9% are black. According to the company, 33% of the participants were obese and 38% were 50 years and older.
Regeneron’s therapy is part of a class of treatments known as monoclonal antibodies, which act as immune cells and fight infections. Monoclonal antibody treatments have attracted widespread attention after news that Trump received Regeneron’s drug in October.
In recent months, public health officials have become concerned that emerging, highly contagious coronavirus variants could pose threats to existing monoclonal antibodies on the market. But dr. Myron Cohen, who is leading the monoclonal antibody efforts for the COHID prevention network sponsored by NIH, said the drug has been shown to maintain its potency against new strains.
While the world’s attention has shifted to the administration of Covid-19 vaccines, health experts say treatments are also critical to ending the pandemic, which infects more than 31.1 million Americans and within a little over a year killed at least 561,800. by Johns Hopkins University.