FDA pulls U.S. authorization for Lilly coronavirus drug

WASHINGTON (WISH) — Bebtelovimab, a coronavirus drug from Indianapolis-based Eli Lilly and Company, is no longer authorized for emergency use in the United States, the U.S. Food and Drug Administration announced Wednesday.

The FDA says it pulled authorization for the monoclonal antibody treatment because it is “not expected to neutralize” the two dominant subvariants of Omicron, BQ.1 and BQ 1.1.

BQ.1 and BQ 1.1 have become the dominant strains of coronavirus in the United States, surpassing Omicron’s BA.5 subvariant. Data published last week by the Centers for Disease Control and Prevention estimates that the two subvariants were responsible for nearly 60% of COVID-19 cases nationwide.

The FDA’s decision removes authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lavegrio, and Gilead Sciences’ Veklury as treatments for the disease, along with convalescent plasma for some patients.

Lilly and its partners have paused the distribution of bebtelovimab until further notice. The FDA says bebtelovimab could again receive emergency use authorization should disease variants susceptible to the drug become more prevalent in the future.

Bebtelovimab received FDA authorization in February.