Overview

• On July 25, the EMA’s Committee for Medicinal Products for Human Use issued a positive opinion recommending lenacapavir for PrEP in adults and adolescents, with formal EU authorization expected later this year
• Phase 3 PURPOSE 1 and PURPOSE 2 trials showed lenacapavir prevented 99.9–100% of HIV infections and was 89% more effective than daily Truvada in preventing HIV due to higher adherence
• The FDA approved lenacapavir (Yeztugo) on June 18 and WHO guidelines released July 14 hailed long-acting injectable PrEP as a “landmark policy action” and endorsed simplified rapid diagnostic testing
• Gilead Sciences pledged two million no-profit doses through a Global Fund partnership over three years and signed royalty-free licensing agreements for generics in 120 high-incidence countries
• With a $28,218 annual list price and uncertain private insurer and Medicaid coverage, experts warn that high costs could hinder equitable rollout, especially among underserved communities