The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use has recommended lenacapavir for pre-exposure prophylaxis (PrEP), according to a press release from the organization. This viral capsid inhibitor is administered by injection twice a year and is already used in combination with other antiretroviral agents in combination therapy for HIV infection. For prophylaxis, it is prescribed to sexually active adults and adolescents weighing 35 kilograms or more from high-risk groups.
The committee's decision is subject to formal approval by the European Commission, which is expected in the coming months. In July 2025, the US Food and Drug Administration (FDA) approved the prophylactic use of lenacapavir. It was also recently included in official recommendations by the World Health Organization, which issued relevant guidance. At the same time, the Global Fund to Fight AIDS, Tuberculosis and Malaria announced an agreement with lenacapavir manufacturer Gilead Sciences to provide this drug to low- and middle-income countries.
