Manufacturing & Production

The FDA has announced that Eli Lilly’s COVID-19 drug bebtelovimab is not authorised for emergency use in the US, as it is not expected to neutralise the dominant Omicron BQ.1 and BQ.1.1 subvariants.

This announcement leaves Pfizer’s Paxlovid, Merck’s Lagevrio and Gilead Sciences’ Veklury as the standard treatments for COVID-19.

Eli Lilly has halted its commercial distribution of the drug until further information is received from the FDA. The US government has also stopped the fulfilment of pending requests for the drug.

The initial authorisation for bebtelovimad was received in February 2022, after the drug had been discovered by Abcellera and commercialised by Eli Lilly.

The CDC has recently estimated that at least 57% of COVID-19 cases in the US are currently being caused by the Omicron BQ.1 and BQ.1.1 subvariants.

It is not all that unusual for COVID-19 treatments to lose their authorisation, with two monoclonal antibody combinations from Eli Lilly and Regeneron having had their authorisations halted last January, as they were ‘highly unlikely’ to work against Omicron.

Eli Lilly stated 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 neutralisation 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.”