Regeneron is submitting for FDA approval for the antibody drug as a preventive therapy
View of Regeneron Pharmaceuticals corporate, research and development headquarters on Old Saw Mill River Road in Tarrytown, New York.
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Regeneron Pharmaceuticals announced Monday that it would ask the Food and Drug Administration to approve the use of its Covid-19 antibody therapy as a preventative treatment.
The therapy, given to former President Donald Trump shortly after he was diagnosed with Covid-19 last year, has already been approved by the FDA to treat adults with mild to moderate Covid-19 and pediatric patients aged 12 and over approved age who tested positive for the virus and is at high risk of serious illness.
Regeneron said it plans to expand the use of its treatment in the United States after a Phase 3 clinical study jointly conducted by the National Institutes of Health found 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 an average of two weeks faster than those who received a placebo.
“As more than 60,000 Americans continue to be diagnosed with COVID-19 every day, the REGEN-COV antibody cocktail can help provide immediate protection to unvaccinated people exposed to the virus,” said Dr. George Yancopoulos, President and Chief Scientific Officer of Regeneron, said in a press release.
The study included 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 study were Hispanic and 9% were Black. Additionally, 33% of the participants were obese and 38% were 50 years and older, according to the company.
Regeneron therapy belongs to a class of treatments known as monoclonal antibodies, which act as immune cells to fight infections. Monoclonal antibody treatments attracted widespread attention after it was revealed that Trump had received Regeneron’s drug in October.
In recent months, public health officials have raised concerns that emerging, highly contagious variants of coronavirus could threaten monoclonal antibodies on the market. Dr. However, Myron Cohen, who leads monoclonal antibody efforts for the NIH-sponsored COVID Prevention Network, said the drug has shown that it will retain its effectiveness against new strains.
As the world’s attention has shifted to giving Covid-19 vaccines, health experts say treatments are also crucial to ending the pandemic, which, according to compiled data, has topped 31.1 million in just over a year Infected Americans and killed at least 561,800 people from Johns Hopkins University.