By Robin Foster and E.J. Mundell
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 proclaimed in a video released by the White House that the drug had an “unbelievable” effect on his recovery from coronavirus infection, the Washington Post reported.
“I think this was the key,” Trump said, after acknowledging 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.
In his video, Trump said, “I have emergency-use authorization all set, and we’ve got to get it signed now.” However, an FDA spokeswoman told The New York Times Wednesday that the agency does not confirm or deny product applications.
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 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 isn’t 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.
White House approves tougher vaccine development rules
Following weeks of delay, the White House on Tuesday approved tough new rules for coronavirus vaccine developers that will make it unlikely that a vaccine will be approved before Election Day.
The approval came only after the U.S. Food and Drug Administration published the updated guidelines on its website as part of briefing materials for outside vaccine advisers, the Post reported.
The standards, which would be applied to an emergency-use authorization for a vaccine, are similar to the standards for a traditional approval. But the White House has worried that the criteria would delay authorization of a vaccine beyond Nov. 3 and sat on the guidance, the Post reported.
The delayed clearance by the White House came only after White House Chief of Staff Mark Meadows demanded detailed justification from the agency about the tougher criteria, the Post reported. The FDA provided the White House with additional data,