FDA authorizes another antibody treatment to fight omicron
The Food and Drug Administration (FDA) on Friday authorized a new antibody treatment from Eli Lilly, adding another option for fighting the omicron variant.
The FDA said the treatment, called bebtelovimab, works against omicron and is authorized for treatment of mild or moderate COVID-19 in people 12 and older who are at high risk for severe disease.
The agency limited its recommendation by saying it should be used in patients “for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.”
Another antibody treatment from GlaxoSmithKline and Vir Biotechnology has already been authorized to work against omicron. Two others, from Regeneron and a different product from Eli Lilly, were restricted after being found to not be effective against the omicron variant.
“Today’s action makes available another monoclonal antibody that shows activity against omicron, at a time when we are seeking to further increase supply,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
On Thursday, the Biden administration announced that it had purchased 600,000 doses of the treatment to be distributed for free. The first 300,000 doses are expected in February and the second half in March.
“This purchase will add an additional 600,000 courses of treatment to our nation’s ‘medicine cabinet’ that could help prevent severe outcomes for Americans who do get sick with COVID-19,” Secretary of Health and Human Services Xavier Becerra said then.
Officials stress that the treatments are not substitutes for vaccination.
“Our top priority is preventing people from getting sick in the first place, which is why it is critical that Americans continue to get vaccinated and get their booster shot as soon as they’re eligible,” Becerra said.
Paxlovid, made by Pfizer, is another treatment that works against omicron, and comes in pill form, which could make it easier to use.