Gilead Sciences announced that the European Commission (EC) has granted marketing authorization for Yeytuo (lenacapavir), the first and only twice-yearly injectable option for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35kg.

The approval applies across the EU’s 27 member states, as well as Norway, Iceland, and Liechtenstein, and follows a positive opinion from the European Medicines Agency’s CHMP. Yeytuo was reviewed under accelerated timelines as a product of major public health interest and will receive an additional year of market protection for its demonstrated clinical benefit.

“Yeytuo’s rapid authorization underscores both the strength of our data and its potential to help address urgent unmet needs in HIV prevention across Europe,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences.

Clinical support for the approval comes from the Phase 3 PURPOSE 1 and PURPOSE 2 trials. In cisgender women in sub-Saharan Africa (PURPOSE 1), twice-yearly lenacapavir resulted in zero HIV infections among 2,134 participants, showing superiority to daily oral Truvada. In PURPOSE 2, which studied cisgender men and gender-diverse people, lenacapavir prevented infection in 99.9% of 2,179 participants. Lenacapavir was well tolerated with no new safety concerns. Results were published in The New England Journal of Medicine, and Science named lenacapavir the 2024 “Breakthrough of the Year.”

This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option. Gilead has filed for approvals in Australia, Brazil, Canada, South Africa, and Switzerland, with further submissions planned in Latin America and low- and middle-income countries, supported by voluntary licensing agreements and a strategic partnership with The Global Fund to enable access for up to two million people.

There is currently no cure for HIV or AIDS.