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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending lenacapavir, a long-acting injectable HIV-1 capsid inhibitor developed by Gilead Sciences, for pre-exposure prophylaxis (PrEP). This recommendation, granted under accelerated review, targets adults and adolescents at increased risk of sexually acquired HIV-1 infection. The European Commission is anticipated to grant final approval later this year. Upon approval, lenacapavir will be marketed under the trade name Yeztugo across all 27 EU member states, as well as Norway, Iceland, and Liechtenstein.1
Additionally, lenacapavir is expected to receive an extra year of market exclusivity in the EU due to its new indication for prevention. The CHMP also gave a positive opinion through the EU-Medicines for All procedure, which aims to facilitate access in low- and lower-middle-income countries by streamlining WHO prequalification and national regulatory processes.1
In the press release, Dietmar Berger, chief medical officer at Gilead, stated, “This milestone underscores our commitment to reimagining HIV prevention globally, expanding options for populations facing barriers to care.”1
Despite advances in HIV prevention, uptake of PrEP remains limited by stigma and socioeconomic factors. Recent surveillance data reveal an 11.8% increase in new HIV diagnoses from 2022 to 2023 across 30 EU and European Economic Area countries.1
Professor Jean-Michel Molina, Université Paris Cité, emphasized the critical role of long-acting PrEP options such as lenacapavir in overcoming real-world adherence challenges and supporting the EU’s 2030 goal to end new HIV infections.1
What You Need To Know
The European Medicines Agency’s committee gave a positive opinion recommending lenacapavir, a twice-yearly injectable, for HIV prevention in adults and adolescents at risk.
Phase 3 trials showed lenacapavir prevented 99.9–100% of HIV infections, outperforming daily oral PrEP with no new safety concerns.
Lenacapavir is poised for EU market approval with extended exclusivity and aims to improve global access, especially in low- and middle-income countries.
Clinical Trial Data
The positive CHMP opinion is supported by results from Phase 3 PURPOSE 1 and PURPOSE 2 trials:
- PURPOSE 1 enrolled 2,134 cisgender women in sub-Saharan Africa. There were zero HIV infections in the lenacapavir arm, demonstrating 100% efficacy and superiority versus daily oral Truvada (emtricitabine/tenofovir disoproxil fumarate).
- PURPOSE 2 enrolled 2,179 cisgender men and gender-diverse participants across multiple regions. Only two HIV infections occurred in the lenacapavir group, indicating 99.9% prevention efficacy and superiority over daily oral Truvada.
Lenacapavir is approved in multiple countries for the treatment of multi-drug-resistant HIV-1 in adults, and in the United States for PrEP in adults and adolescents weighing at least 35 kg. As a novel HIV-1 capsid inhibitor, lenacapavir targets multiple viral lifecycle stages and shows no known cross-resistance with other antiretroviral agents.1
Yeztugo (lenacapavir) is indicated for PrEP to reduce the risk of sexually acquired HIV-1 in adults and adolescents at risk. Patients must test negative for HIV-1 prior to initiation and before each injection to minimize the risk of developing drug resistance.1
Common adverse reactions include injection site reactions, headache, and nausea. Adherence to the twice-yearly dosing schedule is critical to maintain efficacy and reduce resistance development.1
Listen to our full interview with Jared Baeten, MD, PhD, senior vice president of clinical development and virology at Gilead from the approval: FDA Approves Gilead’s Twice-Yearly Injectable Lenacapavir (Yeztugo) for HIV Prevention