FDA: Bebtelovimab Does Not Neutralize New Omicron Subvariants

Bebtelovimab is not expected to neutralize COVID-19 omicron subvariants BQ.1 and BQ.1.1, the FDA said in an updated Healthcare Provider Fact Sheet for bebtelovimab. Bebtelovimab is a monoclonal antibody developed by AbCellera and Eli Lilly to treat COVID-19. The agency granted the monoclonal antibody emergency use authorization to treat mild-to-moderate COVID-19 in February 2022.

The FDA said bebtelovimab is not authorized to treat mild-to-moderate COVID-19 in geographic regions “where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information.” The agency recommends prescribers monitor CDC regional variant frequency data and refer to the Antiviral Resistance information in the Healthcare Provider Fact Sheet for details regarding specific variants and resistance against SARS-CoV-2 variants, particularly omicron subvariants BQ.1 and BQ.1.1.

Several treatments are authorized or approved to treat certain patients with mild-to-moderate COVID-19 and are expected to retain activity against currently circulating variants, including omicron subvariants BQ.1 and BQ.1.1, the FDA said.

One of the primary effective treatments is Pfizer’s Paxlovid (nirmatrelvir and ritonavir) tablets for mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older) who are at high risk for progression to severe COVID-19. Pfizer has submitted an NDA for full approval.

Related: Pfizer Submits NDA for Paxlovid For COVID-19

Gilead’s Veklury (remdesivir) is also effective against the new subvariants. It is approved to treat adults and pediatric patients (28 days of age and older) who have have mild-to-moderate COVID-19 and who are at high risk for progression to severe COVID-19. A third therapeutic is Lagevrio (molnupiravir) developed by Merck and Ridgeback Biotherapeutics. It is a authorized for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19.

“Healthcare providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19,” the agency said.