European regulators have endorsed a new HIV prevention treatment—a twice-yearly injection developed by Gilead Sciences—that is being hailed as a potential game-changer in the global fight against HIV.
The drug, lenacapavir, has emerged as one of 2024’s most significant medical breakthroughs. Unlike traditional daily pills, this long-acting injectable form of pre-exposure prophylaxis (PrEP) offers sustained protection against HIV and showed 100% efficacy in clinical trials.
Lenacapavir works by inhibiting the replication of the HIV virus, significantly reducing the risk of infection in both adults and adolescents. It represents a promising new option for populations who may struggle with daily adherence or face barriers to regular healthcare access.
Gilead announced that the European Medicines Agency’s (EMA) advisory committee issued a positive scientific opinion, paving the way for final approval by the European Commission in the coming months. Once approved, the drug will be marketed in the EU under the name Yeytuo.
“This milestone reflects our commitment to reimagine HIV prevention in Europe and globally,” said Dr. Dietmar Berger, Chief Medical Officer at Gilead Sciences. “Lenacapavir for PrEP could become a vital public health tool, especially for those who face the greatest barriers to care.”
Despite decades of progress in HIV prevention and treatment, new infections remain a concern. In 2023, over 24,700 new HIV cases were reported across the EU, Iceland, Liechtenstein, and Norway—a 11.8% increase from the previous year.
The US Food and Drug Administration (FDA) approved lenacapavir in June 2025. Gilead has also committed to expanding global access by licensing generic versions of the drug in 120 low- and middle-income countries with high HIV prevalence. However, the extent of its global rollout remains uncertain, particularly in the wake of recent U.S. funding cuts to international HIV programs.
Both the EMA and European Commission have yet to issue formal comments on the approval timeline.