HIV prevention: Gilead's vaccine breakthrough nears EU approval
EMA the decision on Thursday (July 24) clears the way for approval by the European Commission later this year, following similar regulatory clearance in the United States in June 2025.
Lenacapavir, a HIV pre-exposure prophylaxis (PrEP), is to be marketed in Europe under the brand name Yeytuo, is a long-acting injectable designed to prevent HIV infection with just two subcutaneous doses annually, following an initial oral lead-in. This innovative therapy is part of a new class of HIV-1 capsid inhibitors that disrupt multiple stages of the viral replication cycle. It represents the first and only twice-yearly PrEP option for individuals at risk of HIV, offering a significant alternative to the currently available daily oral pills like Truvada (TDF/FTC).
Clinical trials have demonstrated strong efficacy. In the PURPOSE 1 trial, conducted among over 5,000 cisgender women and adolescent girls in South Africa and Uganda, lenacapavir achieved 100% efficacy—zero new HIV infections were reported in the treatment group.
A second trial, PURPOSE 2, involving a broader group of cisgender men, transgender, and non-binary adults, showed a 96% reduction in HIV risk compared to those on daily PrEP. These results prompted early unblinding of both trials due to overwhelming benefit. Participants also reported high satisfaction with the twice-yearly regimen, citing ease of adherence, reduced stigma, and fewer missed doses compared to daily pills.
Gilead's chief medical officer, Dr. Dietmar Berger, was on Friday quoted in reports saying that lenacapavir 'has the potential to become a critical tool for public health,' especially for individuals who face barriers to consistent healthcare access. The product is expected to play a vital role in addressing rising HIV infections in Europe, where more than 24,700 new diagnoses were reported in 2023—an 11.8% increase from the previous year across the EU, Iceland, Liechtenstein, and Norway.
Beyond Europe, Gilead is pursuing a global access strategy for lenacapavir. The company has licensed the drug for generic production in 120 low-and lower-middle-income countries and is working toward WHO prequalification and inclusion in international HIV prevention guidelines. It is also eligible for EU-M4all procedures, which would streamline regulatory pathways for resource-limited settings.
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