Lilly's Covid-19 mAb no longer authorized due to Omicron subvariants, FDA says
The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.
The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.
The US government recommends all bebtelovimab supplies be retained by states in the event that variants susceptible to the treatment, which are still currently circulating at lower prevalence, become more prevalent in the future.
Lilly said in a statement that both the company and the FDA
agree that it is not medically appropriate, at this time, to treat high-risk patients with mild-to-moderate COVID-19 with bebtelovimab in the US. Based on pseudovirus data, Lilly can confirm that bebtelovimab does not retain neutralization activity against the BQ.1 and BQ.1.1 variants, most likely due to an aminoacid K444T substitution. Lilly will pause all distribution of bebtelovimab. Any unused bebtelovimab may be kept during the pause.
But bebtelovimab isn’t the first Covid-19 treatment to lose its efficacy due to new variants. Last January, two monoclonal antibody combos from Eli Lilly and Regeneron had their authorizations halted and shipments ceased because HHS said they are “highly unlikely” to work against Omicron.
And unlike with Lilly’s former mAb bamlanivimab, which had its EUA revoked in April 2021, FDA opted to revise, rather than revoke, these three mAb EUAs.
Available Covid-19 therapies in the US include Pfizer’s Paxlovid, Merck’s Lagevrio and Gilead’s Veklury.