Maker of Antibody Cocktail Trump Took Seeks Emergency Use Authorization
Although effectiveness has not yet been seen in humans, drug has shown promise in treating mild cases of COVID-19
THURSDAY, Oct. 8, 2020 (HealthDay News) -- Regeneron Pharmaceuticals Inc. said Wednesday that it is seeking emergency approval from the U.S. Food and Drug Administration for an experimental antibody cocktail given to President Donald Trump shortly after he was diagnosed with COVID-19.
Hours before the company made the announcement, Trump said in a video released by the White House that the drug had an "unbelievable" effect on his recovery from COVID-19, the Washington Post reported. In the video, Trump acknowledged that the antibody cocktail was one of several drugs he was prescribed by his medical team. While there is no hard evidence yet proving the drug's effectiveness in humans, it has shown promise in treating mild cases of the new coronavirus, the Post reported.
Regeneron said in its statement that it could initially produce doses of the antibody cocktail for 50,000 patients and then ramp production up to doses for 300,000 patients in the next few months if granted emergency use authorization. The antibody cocktail is now in late-stage testing. The company has granted fewer than 10 "compassionate use" requests allowing people not enrolled in its trials to use the drug, the Associated Press reported.
The U.S. government first inked a contract with Regeneron back in July and has promised to distribute initial doses of the treatment at no cost if it is approved, the Post reported.
Regeneron is not the only company developing an antibody cocktail to battle COVID-19 infection: Eli Lilly and Co. announced earlier on Wednesday that it was seeking emergency use authorization from the FDA for a similar cocktail. Both treatments use lab-made antibodies to give patients' immune systems a boost. In both cases, scaling up production to meet demand is expected to be a major challenge, the Post reported.