FDA approves emergency use of coronavirus treatment from Regeneron
A COVID-19 treatment from the Tarrytown-based biotech company Regeneron has received authorization from the Food and Drug Administration for emergency use.
Doctors will now be able to use Regeneron's antibody cocktail to treat high-risk coronavirus patients and patients who have mild to moderate symptoms.
Examples of people who are high-risk include those who are over the age of 65 or have pre-existing conditions.
This treatment works best when used early on after diagnosis. The cocktail is being shipped nationwide, and works by mimicking an immune system’s response to an infection.
It’s already reduced COVID-19-related hospitalizations and emergency room visits for patients across the U.S., including President Trump who was treated with the antibody cocktail after his coronavirus diagnosis.
"The FDA is starting to act in a very, very fast fashion to respond to the urgent needs of this community for tools like this that we need, physicians like me and other providers like me need to counteract this virus," says Dr. Harish Moorjani, infectious disease consultant.
Regeneron says it will have doses ready for 80,000 patients this month, and enough for more than 500,000 patients by the end of January.
The government will establish who gets the initial supply, which is enough for 300,000 people.
Regeneron says that the demand for the treatment will probably exceed the supply early on.
The company's CEO is urging federal and state governments to distribute the drug fairly and to those who need it most.
To get full approval from the FDA, beyond just emergency use authorization, Regeneron will have to submit additional research, proving the therapy is safe and effective.