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 its Covid-19 antibody therapy 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 approved by the FDA for the treatment of adults with mild to moderate Covid-19 and pediatric patients at least 12 years old. age who has tested positive for the virus and are at high risk of serious illness.
Regeneron said it wants to expand the use of its treatment in the US after a phase three clinical trial jointly led by the National Institutes of Health found the drug reduced individuals’ risk of symptomatic infections by 81%.
The company also said that people who were symptomatic and treated with the drug recovered their symptoms an average of two weeks faster than those who received a placebo.
“With more than 60,000 Americans still being diagnosed with COVID-19 every day, the REGEN-COV antibody cocktail can help provide immediate protection for unvaccinated people exposed to the virus,” says Dr. George Yancopoulos, president and chief Scientific Officer 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 with someone who recently tested positive. The participants received either one dose of Regeneron therapy or a placebo.
The company said 41% of the people in the process were Hispanic and 9% black. In addition, 33% of the participants were obese and 38% were 50 and older, according to the company.
Regeneron therapy is part of a class of treatments known as monoclonal antibodies, which are made to act like immune cells and fight infection. Monoclonal antibody treatments received widespread attention following the 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 a threat to existing monoclonal antibodies on the market. But Dr. Myron Cohen, who leads the monoclonal antibody efforts for the NIH-sponsored COVID Prevention Network, said the drug has maintained its potential 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, according to data collected, has reached more than 31.1 years in just over a year. million Americans and killed at least 561,800 people. by Johns Hopkins University.