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 announced Monday that it will ask the Food and Drug Administration to allow its Covid-19 antibody therapy 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 12-year-old pediatric patients such as at least. of age that has tested positive for the virus and has a high risk of serious illness.
Regeneron said he wants to expand the use of his treatment in the United States 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 people by 81%.
The company also said people who were symptomatic and were 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 diagnosed with COVID-19 every day, the REGEN-VOC antibody cocktail can help provide immediate protection to unvaccinated people who are exposed to the virus,” said Dr. George Yancopoulos, president and chief scientist of Regeneron, said in a press release.
The trial enrolled 1,505 people who were not infected with the virus but lived in the same home with someone who recently tested positive. Participants received a dose of Regeneron therapy or a placebo.
The company said 41% of the people in the trial were Hispanic and 9% were black. In addition, 33% of participants were obese and 38% were 50 or older, according to the company.
Regeneron therapy is part of a class of treatments known as monoclonal antibodies, which act as immune cells and fight infections. Treatments with monoclonal antibodies caught the eye after news of Trump receiving Regeneron’s drug in October.
In recent months, public health officials have been concerned that emerging, highly contagious coronavirus variants could pose threats to monoclonal antibodies on the market. But Dr. Myron Cohen, who leads monoclonal antibody efforts for the NIH-sponsored COVID Prevention Network, said the drug has been shown to maintain its potency against new strains.
While the world’s attention has focused on the administration of Covid-19 vaccines, health experts say treatments are also critical to ending the pandemic, which has infected more than 31.1 million of Americans and has died at least 561,800 in just over a year, according to data collected by Johns Hopkins University.