Sotrovimab

• The FDA has granted emergency use authorization to Eli Lilly's bebtelovimab for treating mild-to-moderate COVID-19 in high-risk patients aged 12 and older. • The US government has placed a $720 million order for up to 600,000 doses of bebtelovimab, with initial deliveries expected by March end. • Clinical data shows bebtelovimab retains full neutralizing activity against the Omicron variant and its subvariants, offering a crucial treatment option as other antibody therapies lose effectiveness.

The FDA has revoked the Emergency Use Authorization (EUA) for sotrovimab due to the expiration of all manufactured lots under EUA 100.

• The FDA has revoked the Emergency Use Authorizations (EUAs) for four monoclonal antibody products used in the U.S. government's COVID-19 response. • The revoked EUAs include treatments from Eli Lilly, AstraZeneca, Vir Biotechnology, and Regeneron Pharmaceuticals due to the rise of resistant SARS-CoV-2 variants. • These monoclonal antibody products have not been authorized for patient administration for over a year because of ineffective against current variants. • Healthcare facilities will receive instructions from the sponsors for the return and disposal of the revoked products.

• The FDA has fully revoked the emergency use authorization for GlaxoSmithKline and Vir Biotechnology's sotrovimab due to its reduced efficacy against the Omicron sub-variant BA.2. • Sotrovimab initially received EUA based on Phase III trial data showing an 85% reduction in hospitalization or death risk for high-risk COVID-19 patients. • Despite GSK and Vir's claims of efficacy with higher doses, the FDA's decision reflects broader concerns about the treatment's ability to neutralize BA.2. • GSK and Vir plan to submit for full approval of sotrovimab and initiate trials to assess its potential in preventing symptomatic COVID-19 in immunocompromised individuals.

• The FDA has suspended the authorization of GlaxoSmithKline and Vir Biotechnology's sotrovimab in regions where the Omicron BA.2 subvariant is dominant, citing inefficacy. • Sotrovimab, a monoclonal antibody, was previously authorized for treating high-risk COVID-19 patients but shows reduced effectiveness against the BA.2 subvariant. • Eli Lilly's bebtelovimab remains an authorized monoclonal antibody treatment, while oral antivirals also offer alternatives against BA.2. • GSK and Vir are preparing data on a higher dose of sotrovimab for the Omicron BA.2 subvariant for review by regulatory bodies.