The European Medicines Agency (EMA) has issued a positive recommendation for the authorization of lenacapavir, a twice-yearly injectable medication for HIV prevention. Marketed in Europe under the name Yeytuo by Gilead Sciences, the drug is now positioned for formal approval by the European Commission, which would allow its use across all 27 European Union member states, along with Iceland, Norway and Liechtenstein.
Lenacapavir is a pre-exposure prophylaxis (PrEP) medication that has demonstrated near-total effectiveness in preventing HIV transmission. In two large Phase 3 clinical trials, PURPOSE 1 and PURPOSE 2, the drug was found to be 100 percent effective among women in sub-Saharan Africa and 99.9 percent effective among men and gender-diverse individuals in multiple countries, including Argentina, Thailand and the United States.
The twice-yearly injection is the longest-acting PrEP option to date, offering a practical alternative to daily oral medications and existing injectable therapies administered every two months. The EMA’s Committee for Medicinal Products for Human Use reviewed the medication under an accelerated process, citing its major public health relevance. Public health officials and global health organizations have emphasized the significance of lenacapavir in the broader strategy to halt HIV transmission.
Global health officials call for equitable access to lenacapavir
The World Health Organization (WHO) recently recommended lenacapavir as an additional option for individuals at high risk of acquiring HIV. The United States Food and Drug Administration approved the same drug for prevention use in June. Despite significant advances in prevention, challenges remain. PrEP uptake is often hampered by stigma, limited access to healthcare and the need for strict adherence to daily regimens.
Experts believe that lenacapavir’s long-acting nature can help reduce these barriers. Winnie Byanyima, executive director of the Joint United Nations Programme on HIV/AIDS (UNAIDS), has previously described lenacapavir as potentially transformative for global HIV prevention efforts, urging equitable distribution. Concerns have also been raised regarding the accessibility of the drug. Although Gilead has entered licensing agreements to allow generic production in 120 low-income countries, regions such as Latin America, where HIV incidence is rising, are largely excluded.
High price and limited access spark global distribution concerns
The medication currently sells for more than $28,000 annually in the United States, raising questions about affordability in middle-income countries. The EMA also assessed lenacapavir through its EU-M4All program, which enables faster regulatory approvals in collaboration with the WHO for nations outside the European Union. This approach is intended to improve access in countries with high unmet medical needs.
According to the latest UNAIDS data, an estimated 40 million people are living with HIV globally, and approximately 630,000 individuals died from AIDS-related illnesses in 2024. As public health agencies and advocacy groups push for expanded access, lenacapavir is being viewed as a critical tool in the international effort to end HIV transmission by 2030. – By Content Syndication Services.