Regeneron says it has applied to the US Food and Drug Administration for emergency use authorization for its experimental monoclonal antibody therapy, the same antibody cocktail given to President Donald Trump Friday after he was diagnosed with coronavirus.
The biotechnology company confirmed it had submitted the EUA application in a statement on its website Wednesday night.
“Under our agreement with the US government for the initial doses of REGN-COV2, 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 statement said.
“At this time, there are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months.”
Regeneron's experimental antibody treatment is still in large-scale clinical trials, but has been available for compassionate use, something the FDA has to approve on an individual basis, like it did for Trump.
“REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19,” the company said in its statement.
“When you weigh the potential benefit versus the risks, the downsides are very low here because we have not seen any safety concerns,” Regeneron CEO Dr. Leonard Schleifer told CNN in an interview last week after Trump received an 8-gram dose of the treatment, which includes two engineered versions of immune system proteins.
Some early data from trials of the antibody treatment released last week showed it worked fairly safely with few side-effects.
“This class of drugs is an extremely safe class,” Schleifer said.