The European Commission has approved a twice-yearly injection to prevent HIV, marking a breakthrough in public health across the European Union. The decision follows a positive recommendation from the European Medicines Agency (EMA) and paves the way for the rollout of the drug developed by Gilead Sciences.
The medicine, lenacapavir, marketed as Yeytuo, is the first twice-yearly pre-exposure prophylaxis (PrEP) option available in the EU, Norway, Iceland, and Liechtenstein. Unlike daily pills, this long-acting jab prevents the HIV virus from replicating, significantly lowering the risk of infection in both adults and adolescents.
In clinical trials, the injection showed 100% effectiveness in preventing HIV transmission, leading experts to call it one of the most important medical advances of 2024.
Dr. Dietmar Berger, chief medical officer at Gilead, said the approval highlights the urgent need for innovative HIV prevention tools in Europe, where new diagnoses rose by nearly 12% in 2023, with more than 24,700 new cases reported.
The US FDA has also approved lenacapavir, and the World Health Organization (WHO) has endorsed it as an additional option for HIV prevention. Gilead is seeking regulatory clearance in countries including Australia, Brazil, Canada, South Africa, and Switzerland, and plans to extend applications to Argentina, Mexico, and Peru.
To expand access, Gilead has agreed to license generic versions of the drug in 120 low-income countries with high HIV prevalence. However, concerns remain over global availability due to recent US funding cuts for HIV programs.
Globally, an estimated 40.8 million people live with HIV, and more than 630,000 deaths were attributed to AIDS-related illnesses in 2023.