FDA revokes Eli Lilly's COVID-19 drug's authorization

The FDA pulled its emergency use authorization for Eli Lilly's bebtelovimab Nov. 30, which was the only monoclonal antibody treatment to be authorized for COVID-19. 

"Bebtelovimab is not approved for any use, including for use as treatment of COVID-19," according to the FDA, which hinted at this move in October when the agency said the drug is not as effective against omicron subvariants BQ.1 and BQ.1.1, which now account for a majority of infections. 

In an updated fact sheet for the drug, the FDA said the two subvariants "showed a large reduction in susceptibility," or a 672-fold drop, ​​to bebtelovimab.

The drugmaker began selling the drug commercially in August for about $2,100 per vial, a decision that Eli Lilly's chief scientific and medical officer Daniel Skovronsky, MD, PhD, attributed to less federal funds. 

Eli Lilly did not immediately respond to Becker's request for comment.

 

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