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Decision on Yeytuo/ EC approves new preventive vaccine against HIV

2025-08-26 17:15:00, Kosova & Bota CNA

Decision on Yeytuo/ EC approves new preventive vaccine against HIV

The European Commission today granted Gilead Sciences (GILD) approval for its new twice-yearly preventive HIV vaccine, now called Yeytuo.

The approval comes two months after the Food and Drug Administration approved Yeztugo, the brand name of the drug in the U.S. The twice-yearly vaccine has been shown to be 99.9% effective in preventing the spread of the virus in people at risk of contracting HIV.

Gilead said Yeytuo is the first and only twice-yearly pre-exposure prophylaxis, or PrEP, treatment available in the 27 member states of the European Union, as well as Norway, Iceland and Liechtenstein.

The approval has been accelerated with the Committee for Medicinal Products for Human Use describing Yeytuo as a product of "great public health interest".

"The rapid authorization of Yeytuo by the European Commission underscores the rigor of our clinical data and the transformative potential of Yeytuo to help address the urgent unmet need in HIV prevention across Europe," Gilead Chief Medical Officer Dietmar Berger said in a written statement.

The application for marketing authorization was reviewed under an accelerated timeline based on the assessment by the Committee for Medicinal Products for Human Use of the European Medicines Agency that Yeytuo, taken twice a year, is a product of great public health interest.

In July, the CHMP adopted a positive opinion recommending Yeytuo for EC authorisation. In addition, lenacapavir will be granted an additional year of market protection in the EU as a result of the new indication, following a pre-authorisation scientific assessment showing that it brings significant clinical benefits compared to existing therapies./CNA





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