Posted by Michael Wonder on 25 Feb 2025
EMA validates Gilead’s marketing authorisation application and EU-Medicines for all application for twice yearly lenacapavir for HIV prevention
24 February 2025 - One application seeks European Commission authorisation; other application would facilitate availability in low and lower middle income countries.
Gilead Sciences today announced that the EMA has validated for parallel accelerated review the company’s marketing authorisation application and EU-Medicines for all (EU-M4all) application for lenacapavir—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis.
