Gilead Sciences Inc. has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use $(CHMP)$ has adopted a positive opinion under accelerated review for lenacapavir, recommending its use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents at increased risk. If approved by the European Commission later this year, lenacapavir will be marketed in the EU under the trade name Yeytuo®. This development represents a significant step towards introducing a twice-yearly HIV prevention option in Europe. Additionally, a positive opinion was received for the EMA's EU-M4all procedure, which aims to facilitate the drug's availability in low- and lower-middle-income countries. This initiative is part of Gilead's broader global access strategy, designed to expedite regulatory review and expand access to lenacapavir for those most in need.