Regeneron Files for EUA for COVID-19 Monoclonal Antibody
Regeneron Pharmaceuticals submitted a request for Emergency Use Authorization (EUA) for its COVID-19 antibody treatment Thursday, just one day after Eli Lilly filed for authorization of its own monoclonal antibody.
In its announcement, Regeneron said that there are currently enough doses of the investigational antibody cocktail, REGN-COV2, for approximately 50,000 patients. The company said it expects to increase that supply within the next few months to treat approximately 300,000 patients, but that number is unlikely to meet current demand, with the CDC reporting Thursday that the U.S. has seen 314,900 COVID-19 cases in the past week alone.
Still, “if an EUA is granted, the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution,” the company said, adding that if it ends up receiving approval, the treatment will be distributed by Regeneron in the U.S. and by Roche internationally.
REGN-COV2, is a combination of two monoclonal antibodies designed to block viral infection. It was recently in the spotlight for being a part of President Trump’s COVID-19 treatment regimen (DID, Oct. 5). The president touted Regeneron’s treatment on Wednesday, saying the treatment made him feel good “immediately.”
“We have Regeneron, we have a very similar drug from Eli Lilly, and they’re coming out,” he said. “We’re trying to get them on an emergency basis. We’ve authorized it, I’ve authorized it, and if you’re in the hospital … I think we’re going to work it so that you get them, and you get them free. I have Emergency Use Authorization all set, and we’ve got to get it signed now.”
Early data presented by Regeneron at the end of September showed the drug appeared to help nonhospitalized COVID-19 patients in a 275-patient phase 1/2/3 trial. Only 7.7 percent of the patients treated with a high dose of the antibody and 4.9 percent of patients given a low dose required additional medical visits, compared to 15.2 percent of those on placebo. The more virus patients had in their systems, the greater the reduction in the viral load compared to placebo, the company said (DID, Sept. 30).
During a televised interview Thursday, Anthony Fauci, the director of the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), lent credibility to Regeneron’s antibody treatment.
“The data, the preliminary data for those antibodies, are favorable. I think it’s a reasonably good chance that the Regeneron antibody made a significant difference in a positive way in [the president’s] course. There is a reasonably good chance that that in fact made him much better,” Fauci said, though he cautioned that data from a large clinical trial is needed to conclusively determine the antibody’s viability as a COVID-19 treatment.
The treatment is currently being evaluated in three other late-stage trials for COVID-19, including the UK’s RECOVERY trial. — James Miessler