The FDA has approved the experimental Regeneron Pharmaceuticals Inc.’s antibody cocktail administered to President Trump when he contracted the coronavirus. It can now be administered to people with mild to moderate COVID symptoms, with hopes of preventing them from being hospitalized.
Health and Human Services Secretary Alex Azar celebrated the news in a Monday press conference.
“Authorization and distribution of this new Regeneron antibody treatment is another significant step forward in treating patients and bridging us to the rollout of safe and effective vaccines, with all of these efforts made possible by Operation Warp Speed,” Azar said. “Federal allocation of therapeutics like Regeneron’s, in cooperation with our state and local government partners, will help ensure that they go to the patients who need them the most, just days after the product is authorized.”
Thirty thousand doses are expected to be shipped out on Tuesday. By the end of the month Regeneron said they should be able to treat 80,000 patients.
“We are committed to the equitable and efficient distribution of resources like casirivimab and imdevimab to help prevent hospitalization from COVID-19 as much as possible,” said HHS Assistant Secretary for Preparedness and Response Robert Kadlec, M.D. “To that end, we are coordinating with Regeneron, its distributor, and state and territorial health departments to get therapeutics into the hands of healthcare providers quickly, with a focus on areas of the country currently hardest hit by the pandemic.”
At least two vaccine candidates from Pfizer and Moderna have proven to be more than 94 percent effective in clinical trials. So we expect to see more FDA approvals in the coming days.