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Regeneron, located in Tarrytown, submitted an application to the Food and Drug Administration for emergency approval of the antibody cocktail that has been praised by Trump as a “cure” for COVID-19, though there is no proof if the treatment had any impact in his particular case.
According to the company, access to the treatment would be limited, with enough doses for 50,000 patients out the gate.
In a lengthy video touting the experimental treatment as a cure, Trump implied that he would push the FDA to approve Regeneron’s cocktail, alleging - incorrectly - that he “has emergency use authorization all set,” adding “we need to get this signed now.”
The FDA has not made a public comment on the drug or the treatment.
The cocktail, dubbed REGN-COV2, is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block the infectivity of SARS-CoV-2, the virus that causes COVID-19.
- Related story - COVID-19: Westchester-Based Regeneron Creating 500K Test Kits For State At No Charge
Regeneron had previously said that the antibody cocktail reduced viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19 and showed positive trends in reducing medical visits.
"After months of incredibly hard work by our talented team, we are extremely gratified to see that Regeneron's antibody cocktail REGN-COV2 rapidly reduced viral load and associated symptoms in infected COVID-19 patients," said George Yancopoulos, President and Chief Scientific Officer of Regeneron. "The greatest treatment benefit was in patients who had not mounted their own effective immune response, suggesting that REGN-COV2 could provide a therapeutic substitute for the naturally-occurring immune response.
“We are highly encouraged by the robust and consistent nature of these initial data, as well as the emerging well-tolerated safety profile, and we have begun discussing our findings with regulatory authorities while continuing our ongoing trials,” Yancopoulos added.
"In addition to having positive implications for REGN-COV2 trials and those of other antibody therapies, these data also support the promise of vaccines targeting the SARS-CoV-2 spike protein."
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