The European Commission authorizes the first biannual injection to prevent HIV.

The European Commission (EC) has approved the marketing of the injectable drug lenacapavir (Yeytuo) as pre-exposure prophylaxis (PrEP) to reduce the risk of sexual transmission of HIV , the virus that causes AIDS, in adults and adolescents at increased risk of infection who weigh at least 35 kg. This is the first and only biannual PrEP option authorized for use in all 27 Member States of the European Union, as well as in Norway, Iceland, and Liechtenstein.

The marketing authorisation application was assessed under an accelerated procedure based on the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), which considered that this biannual preventive injectable therapy is of major public health interest . In July, the CHMP adopted a positive opinion recommending this therapy for EC authorisation. In addition, the new indication will allow the medicine to have an additional year of market protection in the EU following a prior scientific assessment which determined that it provided a significant clinical benefit compared to existing therapies .

"The EC's rapid approval of Yeytuo reflects both the rigor of our clinical data and the transformative potential of this therapy," said Dietmar Berger, Chief Medical Officer of Gilead Sciences. "This milestone is the result of 17 years of research at Gilead that have made this innovative PrEP medicine possible, supported by decades of leadership in HIV innovation."

The EC authorization follows approval by the U.S. Food and Drug Administration (FDA) in June, as well as the publication of World Health Organization (WHO) guidelines in July recommending its use as an additional PrEP option for HIV prevention.

“With around 25,000 new HIV diagnoses each year in the EU and the European Economic Area, it’s clear that current prevention options don’t work for everyone who needs or wants them, especially among vulnerable populations,” says Jean-Michel Molina, MD, Université Paris Cité, professor of infectious diseases and head of the Department of Infectious Diseases at Saint-Louis and Lariboisière Hospitals. “The biannual dosing regimen and its high efficacy could be the transformative HIV prevention option we’ve been waiting for in Europe to help us reduce new infections and make real progress toward ending the HIV epidemic.”

The EC authorization is based on data from Gilead’s Phase 3 PURPOSE 1 and PURPOSE 2 trials. In the PURPOSE 1 trial (NCT04994509), data from the primary analysis showed that none of the 2,134 participants in the group receiving six-monthly subcutaneous lenacapavir developed HIV infection, representing 100% efficacy and statistical superiority in preventing infection compared with daily oral Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; F/TDF) in cisgender women in sub-Saharan Africa.

In the PURPOSE 2 trial (NCT04925752), two HIV infections were reported among 2,179 participants in the 6-monthly subcutaneous dose group, demonstrating that 99.9% of participants receiving the drug did not acquire HIV and that HIV infection prevention was superior compared with daily oral Truvada among a large and geographically diverse group of cisgender men and gender-diverse people.

In both trials, the new PrEP therapy demonstrated superiority in preventing HIV infections compared with baseline HIV incidence (bHIV) and was generally well tolerated, with no new or significant safety concerns identified. Data from both trials were published in The New England Journal of Medicine , and, thanks in part to these results, the journal Science named it " Breakthrough of the Year " in December 2024.

In addition to the authorizations already obtained in the US and the EU, the company has submitted applications to authorities in Australia, Brazil, Canada, South Africa, and Switzerland. It is also preparing new applications in Argentina, Mexico, and Peru.

Following the positive review of the EU-Medicines for All (EU-M4all) initiative for PrEP, Gilead plans to submit applications to regulatory authorities in low- and middle-income countries. These include applications from 18 countries representing 70% of the HIV burden in the 120 countries included in Gilead's previously announced voluntary licensing agreements.