On Feb. 11, the FDA issued an Emergency Use Authorization (EUA) for a new monoclonal antibody (mAb) therapy Bebtelovimab, which has in vitro activity against Omicron including the BA.2 subvariant. We received our 1st shipment of Bebtelovimab this week (30 doses). Providers can follow the same referral process as Sotrovimab.
The EUA was issued for Bebtelovimab in the outpatient setting for those individuals classified as high risk with mild-to-moderate COVID-19 diagnosed within 7 days of positive PCR test. Bebtelovimab is an alternative when neither oral Paxlovid (1st choice) nor IV Sotrovimab (2nd choice) are available.
Like other monoclonal antibody therapies, Bebtelovimab works by binding to the SARS-CoV-2 spike protein to reduce viral replication. Data supporting the EUA of Bebtelovimab comes from the Phase 1/2 BLAZE-4 trial, where Bebtelovimab was shown to improve symptoms in patients with mild-to-moderate COVID-19. Additionally, a reduction in SARS-CoV-2 viral load on Day 5 was observed relative to placebo, though the clinical significance of this is unclear.