The U.S. Food and Drug Administration (FDA) on Saturday granted emergency authorization for the antibody treatment administered to and later praised by President Trump for his past COVID-19 diagnosis.
The antibody cocktail from Regeneron is authorized for treating mild to moderate COVID-19 in adults, as well as pediatric patients at least 12 years old who have a high risk of progressing to severe disease.
The company said it could have enough doses for around 80,000 patients by the end of November, and enough for approximately 300,000 patients in total by the end of January.
Regeneron CEO Leonard S. Schleifer said in a statement that the emergency authorization is “an important step in the fight against COVID-19,” adding that “the science and technology investments Regeneron has made over three decades positioned us to move rapidly to invent, study and maximize production” of the cocktail.
The company filed for emergency approval of the treatment in October after the president praised its efficacy in a video posted on Twitter. The treatment was one of several that he received during his stay at Walter Reed National Military Medical Center to treat his COVID-19 diagnosis last month.
The FDA issued a similar emergency use authorization earlier this month for an Eli Lilly antibody drug to treat mild to moderate COVID-19 cases.
Monoclonal antibodies like Regeneron’s treatment are lab-generated versions of one of the human body’s main defenses against pathogens.
The Trump administration has already placed an order for over one million doses of the treatments. Previously, Regeneron inked a $450 million deal in July to sell enough doses of its drug, REGN-COV2, to the federal government for the treatment of about 300,000 people.
The latest FDA approval comes days after Pfizer and BioNTech also filed for similar emergency authorization for its COVID-19 vaccine.