Posted by Michael Wonder on 05 Feb 2025
Gilead submits marketing authorisation applications to EMA for twice yearly lenacapavir for HIV prevention
3 February 2025 - One application seeks European Commission authorisation; other application would help facilitate availability in low and lower middle income countries.
Gilead Sciences today announced the company has submitted a European Commission marketing authorisation application and an EU-Medicines for All application to the EMA as it seeks licenses for an investigational use of lenacapavir—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis.
