Regeneron asks FDA for emergency use authorization for antibody drug that treated Trump
Regeneron is seeking emergency use authorization from the Food and Drug Administration for its drug that was used to treat President Donald Trump while he was hospitalized with COVID-19.
The pharmaceutical company submitted an application on Wednesday for REGN-COV2, which is described as a combination of two monoclonal antibodies designed specifically to block the infectivity of the novel coronavirus — which causes COVID-19.
In a video released Wednesday, Trump called the drug “a cure” after receiving it during his three-day stay at Walter Reed National Military Medical Center last weekend, though the medical community maintains COVID-19 has no known cure.
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The president tweeted a follow-up video Thursday directed at senior citizens, who he called his “favorite people in the world.” Trump again advocated for the drug to be given emergency use authorization status.
"We're taking care of our seniors," Trump said in the video. "I want you to get the same care that I got."
The safety and effectiveness of the drug have not yet been proven.
Should the drug gain authorization, Regeneron said there’s an agreement in place for the government to make the initial doses available for free.
“If an EUA is granted, the government has committed to making these doses available to the American people at nocost and would be responsible for their distribution,“ Regeneron said in a statement.
The drugmaker said they have enough doses ready for 50,000 patients. They expect to have doses available for 300,000patients in total within the next few months.
This story was reported from Atlanta. Kelly Hayes contributed.