FDA grants emergency use of Covid treatment given to Trump
The FDA on Saturday approved the emergency use of Regeneron's experimental antibody treatment for mild and moderate cases of the coronavirus, which was given to President Donald Trump in October.
The drug is a cocktail of two monoclonal antibodies that mimic the body's natural defenses against the virus. The emergency approval allows the drug to be used in adults and children over 12 years of age with mild to moderate Covid-19 symptoms who are at high risk of developing serious illness or being hospitalized. Treatment is not approved for patients who are hospitalized or need oxygen therapy because of the coronavirus.
Regeneron has released data from a late-stage study showing that the antibody reduces the amount of virus in a person's body and can speed recovery.
"The approval of these monoclonal antibody therapies can help outpatients avoid hospital stays and relieve our health system," said FDA Commissioner Stephen Hahn in a press release.
Background: President Donald Trump, who received the Regeneron antibody cocktail in early October during his battle with Covid-19 and labeled the drug a "cure", put pressure on the FDA to approve such treatments quickly. Eli Lilly also received emergency approval for his antibody drug earlier this month. The approvals may make it difficult for Regeneron and Lilly to complete their ongoing studies and try other antibody treatments to attract participants.
Offer: Regeneron says there will be enough antibody doses for about 80,000 people by the end of the month. By the first week of January, doses are expected to be available for a total of 200,000 patients and 300,000 people by the end of this month.
The Trump administration has signed a $ 450 million contract with Regeneron to provide Americans with up to 300,000 cans of the drug cocktail free of charge. However, healthcare facilities may charge fees to administer the treatment.
However, Len Schleifer, CEO of Regeneron, has warned that there aren't enough antibody treatment doses for everyone who needs one. Regeneron is working with Roche to increase production capacity. Up to 2 million doses could be used to treat Covid-19 or between 4 and 8 million doses to prevent disease over the next year.
What's next? The Department of Health and Human Services will begin distributing Regeneron's antibodies, possibly in a similar way to Lilly's antibodies. The drug is allocated weekly and based on the number of coronavirus cases in each state.
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