A New Era in HIV Prevention
The European Commission (EC) has granted marketing authorization to Gilead Sciences for its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, which will be sold in Europe under the brand name Yeytuo. The approval covers the European Union’s 27 member states, as well as Norway, Iceland, and Liechtenstein.
Yeytuo has been authorized for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kilograms who are at increased risk of infection. This marks the first and only twice-yearly PrEP option approved in the region.
Gilead stated that the EC decision followed an accelerated review timeline based on an assessment by the European Medicines Agency’s Committee for Medicinal Products for Human Use, which determined that the product was of major public health interest. The company noted that lenacapavir will be granted one additional year of market protection in the EU due to its significant clinical benefit compared with existing therapies.
“Yeytuo’s rapid authorization 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,” said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences.
Backed by Robust Clinical Data
The approval was supported by data from two Phase 3 studies, PURPOSE 1 and PURPOSE 2. In PURPOSE 1, which included cisgender women in sub-Saharan Africa, twice-yearly injections of lenacapavir resulted in zero HIV infections among 2,134 participants, demonstrating superiority to once-daily oral Truvada.
In PURPOSE 2, conducted among cisgender men and gender-diverse individuals, two HIV infections occurred among 2,179 participants, reflecting 99.9% of participants remaining uninfected and superiority to daily oral Truvada. Both studies indicated lenacapavir was generally well-tolerated with no significant new safety concerns.
Global Implications and Accessibility
Jean-Michel Molina, MD, Professor of Infectious Diseases at Université Paris Cité, commented that with around 25,000 new HIV diagnoses in the EU and European Economic Area annually, current prevention tools are not sufficient. He added that the novel twice-yearly dosing and high efficacy of Yeytuo could be an important prevention option to reduce new infections.
The EC decision follows U.S. Food and Drug Administration approval in June, where the product is marketed as Yeztugo. In July, the World Health Organization issued guidelines recommending twice-yearly lenacapavir as an additional PrEP option.
Pricing and reimbursement negotiations must now take place in each European country before patient access can begin. In the U.S., Gilead’s list price for Yeztugo is over $28,000 annually, and some insurers have delayed coverage due to cost concerns.
Looking beyond Europe and the U.S., Gilead has filed regulatory submissions in Australia, Brazil, Canada, South Africa, and Switzerland, with plans to submit in Argentina, Mexico, and Peru. The company also intends to seek approvals in low- and middle-income countries, prioritizing registrations in 18 countries representing 70% of the global HIV burden under voluntary licensing agreements.
Through a partnership with the Global Fund to Fight AIDS, Tuberculosis and Malaria, Gilead has committed to supplying lenacapavir for up to two million people in low-income countries over three years, supported by generic manufacturers preparing to produce under royalty-free licenses.
