EU Approves Twice-Yearly HIV Prevention Shot

 

European regulators have given the green light to a twice-yearly injection to prevent HIV—hailed as one of 2024’s most significant medical breakthroughs.

The drug, Lenacapavir, developed by Gilead Sciences, was 100% effective in clinical trials. It offers a much-needed alternative to daily PrEP pills by blocking the virus from replicating and spreading in the body. It's effective for both adults and adolescents and will be sold in Europe under the name Yeytuo once formal approval is granted by the European Commission.

“This milestone reflects our commitment to reimagine HIV prevention in Europe and around the world,” said Dr. Dietmar Berger, Gilead’s Chief Medical Officer. 

“Lenacapavir has the potential to become a critical public health tool, especially for people facing the highest barriers to care.”

The European Medicines Agency (EMA) issued a positive opinion on the injection last week, and the U.S. FDA approved it in June. Health experts believe the simplified twice-yearly regimen could significantly improve adherence and access—two challenges that often limit the success of PrEP programs.

Despite progress, HIV cases are climbing. In 2023, over 24,700 new infections were reported across the EU, Iceland, Liechtenstein, and Norway—an increase of nearly 12% from the previous year.

Worldwide, HIV still affects 40.8 million people, with around 630,000 AIDS-related deaths last year.

Gilead has committed to making generic versions of the drug available in 120 low-income countries. However, global access may be hampered by recent U.S. cuts to international health funding.