As soon as the Food and Drug Administration (FDA) approved emergency use of Regeneron’s monoclonal antibody cocktail to treat COVID-19, the federal government said that it would ship out the first 30,000 doses. Officials said they will distribute additional 50,000 doses on December 2.
On Monday, Secretary of Department of Health and Human Services (HHS) Alex Azar told reporters, “We expect to distribute about 30,000 doses [Tuesday], with more to come in the ensuing weeks.”
The FDA issued an Emergency Use Authorization (EUA) on Saturday for the antibody combination of casirivimab and imdevimab – the therapy received by President Donald Trump in October for his COVID-19 diagnosis.
The therapy is advised only for patients aged 12 and above who have mild to moderate COVID-19. It is given to patients who test positive for the coronavirus and are at risk of developing a serious illness.
Regeneron’s monoclonal antibody is the second therapy approved by the FDA for COVID-19 treatment. Earlier this month, the US drug regulatory body issued an emergency approval to Eli Lilly’s bamlanivimab, another antibody therapy.
Both therapies are available under a prescription. They are infused slowly for an hour and are recommended only for patients who are not hospitalized.
Azar said Monday that the US government had been working to increase interest in the use of the monoclonal antibody therapies developed by Regeneron and Eli Lilly, aiming to keep people out of the hospital.
He said, “HHS has been working to get the word out that if you have tested positive for COVID-19 and are at high risk for severe disease, we have treatment options that may be able to help you. It’s vital that Americans be aware of these expanding options.”
However, last month, Regeneron CEO Leonard Schleifer said “supplies were so tight that the product would have to be rationed.”
After receiving the FDA’s EUA, Regeneron said it has been expecting to have 80,000 doses by the end of November and 200,000 doses by the first week of January.
Dr. John Redd, Chief Medical Officer in HHS’ Office of the Assistant Secretary for Preparedness and Response, told reporters that supply would meet demand.
He said, “We’re very confident in our ability to quickly and fairly allocate casirivimab and imdevimab, as well as bamlanivimab.”
“We’ve been very pleased with the demand for the product,” Dr. Redd added.
The process for distributing the doses of Regeneron’s monoclonal antibody treatment will be the same as the one used for distributing the doses of Eli Lilly’s, Dr. Redd explained.
People will not have to pay for either of these antibody therapies, although those who receive the treatments will have to pay an administration fee. Azar said, “We are working with payers on reimbursement for administration costs.” The article originally appeared on Medscape Medical News.
