Gilead Sciences, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending lenacapavir, an injectable HIV-1 capsid inhibitor, for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents at increased risk. The recommendation was granted under accelerated review.
Pending the final decision from the European Commission (EC) later this year, lenacapavir could soon be marketed in the European Union under the trade name Yeytuo. If approved, it will be available across all 27 EU Member States as well as Norway, Iceland, and Liechtenstein, with an additional year of market exclusivity granted due to the new indication.
The CHMP also issued a positive opinion through the EU-Medicines for all (EU-M4all) pathway, facilitating faster regulatory review in low- and lower-middle-income countries and supporting World Health Organization prequalification.
“This milestone reflects our commitment to reimagine HIV prevention in Europe and around the world,” said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences. He emphasized the potential of lenacapavir as a vital public health tool to expand prevention options for people facing barriers to care.
Despite progress in HIV prevention, social and economic factors continue to drive disparities in PrEP use. In 2023, new HIV diagnoses in the EU/European Economic Area rose by nearly 12%, highlighting the ongoing need for innovative prevention strategies.
Jean-Michel Molina, MD, PhD, Professor of Infectious Diseases at Université Paris Cité, praised the CHMP’s positive opinion as an important step toward meeting Europe’s goal of ending new HIV infections by 2030. He pointed to lenacapavir’s long-acting profile as a way to overcome barriers to PrEP adherence.
The positive opinions were supported by data from Gilead’s Phase 3 PURPOSE 1 and PURPOSE 2 trials. PURPOSE 1 showed zero HIV infections among 2,134 participants receiving twice-yearly lenacapavir, demonstrating superiority over daily oral Truvada in cisgender women in sub-Saharan Africa. PURPOSE 2 found a 99.9% prevention rate among 2,179 participants, with lenacapavir outperforming Truvada in a diverse population of cisgender men and gender-diverse individuals. Both trials confirmed lenacapavir’s safety and tolerability.
These results, published in The New England Journal of Medicine, contributed to lenacapavir being named the 2024 “Breakthrough of the Year” by the journal Science.