Casirivimab

The U.S. monoclonal antibodies market is expected to grow from $94.09 billion in 2025 to $284.90 billion by 2034, driven by rising prevalence of chronic diseases and expanding therapeutic applications beyond oncology.

• 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 LATITUDE study demonstrated that long-acting cabotegravir and rilpivirine showed superior efficacy compared to daily oral care for PLWH with adherence challenges.

• The FDA has revoked the Emergency Use Authorization (EUA) for AstraZeneca's Evusheld due to the expiration of all distributed lots and high prevalence of non-susceptible variants. • Regeneron requested the FDA revoke the EUA for REGEN-COV because all manufactured lots have expired, and the company no longer intends to offer the product in the United States. • Both Evusheld and REGEN-COV were not authorized for use in any region of the U.S. at the time of the requests due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to these treatments. • The FDA determined that revoking these authorizations is appropriate to protect public health and safety, given the reduced efficacy against current variants.

• 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.