On April 16, Lilly announced that it was requesting FDA to revoke the emergency use authorization (EUA) for the monoclonal antibody bamlanivimab (LY-CoV555) when used alone.
Hours after, the agency agreed to rescind the EUA on the grounds that bamlanivimab is potentially ineffective against some SARS-CoV-2 variants.
Bamlanivimab, however, won’t be disappearing as a COVID-19 treatment but will be paired with another monoclonal antibody known as etesevimab.
The combination of bamlanivimab and etesevimab won EUA status on Feb. 9 to treat mild to moderate COVID-19. The combination is more effective against emerging SARS-CoV-2 variants than either antibody alone.
FDA has indicated the combination of bamlanivimab and etesevimab for people 12 years of age and older who tested positive for SARS-CoV-2. To receive the drugs, patients must weigh at least 40 kg (88 pounds) and have a high risk of developing severe COVID-19 or hospitalization.
Some 400,000 people had received bamlanivimab when offered individually as a COVID-19 treatment. Lilly estimates that the antibody prevented more than 20,000 hospitalizations and at least 10,000 deaths.
The company intends to continue developing neutralizing antibodies to combat future SARS-CoV-2 variants that can evade currently authorized therapies.