The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has recommended lenacapavir for use in pre-exposure prophylaxis of HIV infection, the organization said in a press release. This viral capsid inhibitor is injected twice a year and is already used in combination with other antiretroviral agents in the complex therapy of HIV infection. For prophylactic purposes, it is prescribed to sexually active adults and adolescents weighing 35 kilograms from risk groups.
The committee’s decision must receive formal approval from 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 the official recommendations of the World Health Organization, which issued a guideline on the matter. At the same time, the Global Fund to Fight AIDS, Tuberculosis and Malaria announced an agreement with lenacapavir manufacturer Gilead Sciences to provide the drug to low- and middle-income countries.
