Gilead Sciences has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the use of its long-acting injectable HIV-1 capsid inhibitor, lenacapavir, as pre-exposure prophylaxis (PrEP) for individuals at risk of sexually acquired HIV-1.

The recommendation, granted under accelerated review, is for adults and adolescents with increased risk of HIV acquisition. If approved by the European Commission (EC), lenacapavir will become the first and only HIV prevention option administered just twice a year in the European Union.

The EC will now review the CHMP’s recommendation as part of the marketing authorisation process. The decision will apply to all 27 EU Member States, as well as Norway, Iceland and Liechtenstein. Approval would also grant lenacapavir an additional year of market exclusivity in the EU for the new indication.

In parallel, CHMP has adopted a positive opinion under the EU-M4all (EU-Medicines for all) procedure. This mechanism supports World Health Organization (WHO) prequalification and facilitates access in low- and lower-middle-income countries by enabling streamlined national regulatory reviews.

“This milestone reflects our commitment to reimagine HIV prevention in Europe and around the world,” said Dietmar Berger, Chief Medical Officer at Gilead Sciences. “Lenacapavir for PrEP has the potential to become a critical tool for public health, helping to expand prevention options for people who face the highest barriers to care.”

According to the European Centre for Disease Prevention and Control (ECDC), 24,731 new HIV diagnoses were reported in 2023 across 30 EU and EEA countries—an 11.8% increase compared with 2022. While oral PrEP remains available, long-acting alternatives could help address ongoing access gaps due to social, structural, and economic barriers.

“These positive opinions from the CHMP are an important step toward a new HIV prevention option that could help meet the diverse needs of people across Europe and aim at helping end new HIV infections by the EU target of 2030,” said Jean-Michel Molina, Professor of Infectious Diseases at Université Paris Cité and Head of Infectious Diseases at Saint-Louis and Lariboisière Hospitals.

The CHMP decision was supported by data from Gilead’s PURPOSE 1 and PURPOSE 2 trials. PURPOSE 1 involved cisgender women in sub-Saharan Africa, with zero HIV infections recorded among 2,134 participants receiving lenacapavir, showing superiority over once-daily oral PrEP with emtricitabine and tenofovir disoproxil fumarate (Truvada). PURPOSE 2 included 2,179 cisgender men and gender-diverse individuals globally, with two HIV infections reported in the lenacapavir arm—demonstrating 99.9% of participants did not acquire HIV.

Both trials supported lenacapavir’s superiority when compared with background HIV incidence and showed it was generally well-tolerated, with no new or significant safety concerns identified. The data have been published in The New England Journal of Medicine, and in December 2024, Science named lenacapavir its “Breakthrough of the Year.”