Imdevimab

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 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.

The European Medicines Agency (EMA) has approved Ronapreve, developed by Roche and Regeneron, for treating COVID-19 in patients over 12 who do not require oxygen and are at high risk of severe infection.