A Breakthrough in HIV Prevention
The European Commission has officially authorized the sale of Yeytuo, the first long-acting injectable PrEP (pre-exposure prophylaxis) containing lenacapavir. Administered only once every six months, this treatment is set to revolutionize HIV prevention across Europe.
The approval covers all 27 EU member states, as well as Norway, Iceland, and Liechtenstein. It was granted through an accelerated process, following the positive opinion of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
Clinical trials conducted in 2023 demonstrated close to 100% effectiveness in preventing HIV infection. This milestone offers new hope in reducing the more than one million new cases reported annually worldwide (UNAIDS).
Gilead Sciences, the company behind Yeytuo, emphasized the robustness of the clinical data and the transformative potential of this therapy for global public health (Gilead press release).
Global Impact and Accessibility
Beyond Europe, Gilead has already submitted applications for regulatory review in multiple countries, including regions in Latin America. The company has also partnered with The Global Fund to ensure wider access in low- and middle-income countries.
The World Health Organization (WHO) has endorsed lenacapavir as a new preventive tool in the fight against HIV, highlighting its potential to close critical gaps in prevention worldwide.
The approval of Yeytuo marks a historic turning point in HIV prevention. By reducing barriers to adherence and offering long-term protection, this innovation has the power to significantly shift the trajectory of the HIV epidemic—bringing us closer to a world with fewer new infections and stronger community health.