DETROIT – The Food and Drug Administration granted an emergency use authorization for the COVID-19 antibody cocktail produced by Regeneron Pharmaceuticals.
The treatment attracted a lot of attention after President Donald Trump received it. United States Department of Housing and Urban Development director Dr. Ben Carson said it was also critical in his recovery.
The authorization does not mean the treatment will be widely available. A similar treatment from Eli Lilly and Company also received an emergency use authorization.
Many experts had hoped antibody treatments could serve as a bridge to help us save lives while we waited for a vaccine to be developed. It hasn’t worked out that way, at least not yet.
Antibody therapies could reduce the burden on hospitals. The treatment is indicated for people early in their infection. Trump received the Regeron treatment when he was diagnosed with COVID-19 last month.
During clinical trials, Regeneron’s experimental cocktail reduced hospitalizations and ER visits. While the treatment may be helpful for some, getting the treatment to the right patients is proving to be a huge challenge.
The FDA is authorizing Regeneron’s antibody cocktail for some patients who test positive for COVID-19. On Saturday, the FDA gave the OK to give the cocktail to high-risk patients with mild or moderate symptoms. The cocktail contains two antibodies produced in a lab and can be given to patients who are newly infected.
Regeneron said it will have doses ready for 80,000 patients this month, and enough for half a million more by the end of January.
The FDA said it will continue to evaluate the safety and effectiveness of the treatment.