“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 during his battle with Covid-19 in early October and labeled the drug a “cure”, pressured the FDA to quickly approve such treatments. 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.
Deliver: 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 for free. 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 is based on the number of coronavirus cases in each state.