European regulators have taken a major step toward approving a groundbreaking HIV prevention treatment, with a twice-yearly injection from U.S. drugmaker Gilead Sciences receiving a positive opinion from the European Medicines Agency (EMA).
The injectable drug, known as lenacapavir, has been hailed as a “game-changer” in the global fight against HIV. Designed as a long-acting form of pre-exposure prophylaxis (PrEP), the treatment has shown 100% effectiveness in preventing HIV in clinical trials. It works by preventing the virus from replicating and spreading in the body, offering protection for both adults and adolescents.
The EMA’s advisory committee issued its endorsement last Friday, paving the way for formal approval by the European Commission later this year. Once authorized, lenacapavir will be marketed in the EU under the name Yeytuo.
“This milestone reflects our commitment to reimagine HIV prevention in Europe and around the world,” said Dr. Dietmar Berger, Chief Medical Officer at Gilead Sciences. “Lenacapavir for PrEP has the potential to become a critical tool for public health, helping to expand prevention options for people who face the highest barriers to care.”
Unlike existing daily oral PrEP medications, lenacapavir requires only two injections per year, making it a more convenient option and potentially improving adherence among at-risk populations.
Despite significant advancements in treatment and awareness, HIV continues to pose a public health challenge. In 2023, the number of new HIV diagnoses in the EU, along with Iceland, Liechtenstein, and Norway, rose to over 24,700—an 11.8% increase from the previous year.
Lenacapavir was also approved by the U.S. Food and Drug Administration (FDA) last month. While its rollout is expected to begin in Europe soon after final approval, global accessibility remains a concern.
Gilead has agreed to license generic versions of the drug for use in 120 low- and middle-income countries with high HIV prevalence. However, the extent of global distribution is uncertain following significant funding cuts to international health programs by the United States earlier this year.
The European Commission, which will make the final decision on market authorization, has not yet issued a formal response. The EMA also declined to comment further at this stage.
If approved, lenacapavir would mark a major shift in HIV prevention strategies across Europe, potentially reaching those who struggle with daily medication regimens and expanding protection at a time when new infections are once again on the rise.
