Biotechnology company Regeneron has asked the Food and Drug Administration (FDA) for emergency approval of its experimental antibody drug that was used to treat President Trump following his coronavirus diagnosis.
The drug maker on Wednesday announced it requested emergency use authorization from the FDA for REGN-COV2, the antibody cocktail used to boost the body’s response to COVID-19.
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Regeneron said it would make doses available to the American people at no cost under the approval. Currently, doses for about 50,000 patients are available and Regeneron claims it expects to have enough doses for 300,000 people in the coming months.
“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,” Regeneron said in a statement.
In a video posted to Twitter Wednesday, Trump praised the treatment as an “unbelievable” drug claiming without evidence it was a “cure” and promised to provide hundreds of doses to Americans for free.
The president called on regulators to approve Regeneron’s request, along with a similar request made this week for a separate antibody therapy from Eli Lilly.
“I have emergency use authorization all set, and we’ve got to get it signed now,” Trump said in the video.
The antibody therapy is a combination of two monoclonal antibodies designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19.
The experimental treatment is still in clinical trials.
Regeneron released a press release last week claiming it appeared to work safely with few side effects in a study of 275 people, but the drug maker has yet to release the full data for peer review.
Trump was given a single 8 gram dose of the treatment under a compassionate-use request Friday after he announced he and the first lady contracted the virus.
While Trump has claimed the drug has made him feel “incredible,” it’s worth noting he was also given a series of other treatments including remdesivir and dexamethasone, and there’s no evidence Regeneron’s antibody cocktail is responsible for his recovery.
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