Gilead Sciences, Inc. announced that the European Commission (EC) has granted marketing authorization for Yeytuo® (lenacapavir)—the company’s twice-yearly 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 with increased HIV-1 acquisition risk who weigh at least 35kg.
Yeytuo is the first and only twice-yearly PrEP option to be approved for use in the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein.
The marketing authorization application (MAA) was reviewed under an accelerated timeline based on the assessment by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) that twice-yearly Yeytuo is a product of major interest for public health. In July, the CHMP adopted a positive opinion recommending Yeytuo for EC authorization. Additionally, lenacapavir will be granted one additional year of market protection in the EU as a result of the new indication, following a scientific evaluation prior to authorization that it brought significant clinical benefit in comparison to existing therapies.
Yeytuo’s rapid authorization by the European Commission underscores the rigor of our clinical data and the transformative potential of Yeytuo to help address the urgent unmet need in HIV prevention across Europe. This milestone is a testament to the 17 years of Gilead research that delivered this breakthrough PrEP medication, underpinned by decades of leadership in HIV innovation
said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences.
The EC authorization follows approval by the U.S. Food and Drug Administration (FDA) in June, as well as the issuance of guidelines by the World Health Organization (WHO) in July that recommended twice-yearly lenacapavir as an additional PrEP option for HIV prevention.
With around 25,000 new HIV diagnoses in the EU and European Economic Area every year, it’s clear that current prevention options are not working for everyone who needs or wants them, especially among vulnerable populations. Yeytuo’s novel twice-yearly dosing schedule and high efficacy could be the transformative HIV prevention option in Europe we’ve been waiting for to help us reduce new infections and make real progress toward ending the HIV epidemic
said Jean-Michel Molina, MD, Université Paris Cité, Professor of Infectious Diseases and Head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals.
EC authorization of Yeytuo is supported by efficacy and safety data from two Phase 3 trials
The EC authorization of Yeytuo was supported by data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead. In the PURPOSE 1 trial (NCT04994509), data at the primary analysis showed that administration of twice-yearly subcutaneous lenacapavir led to zero HIV infections among 2,134 participants, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) in cisgender women in sub-Saharan Africa. In the PURPOSE 2 trial (NCT04925752), at the primary analysis there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous lenacapavir group, demonstrating 99.9% of participants did not acquire HIV infection and superiority of prevention of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people. In both trials, lenacapavir demonstrated superiority of prevention of HIV infections when compared with background HIV incidence (bHIV) and was generally well-tolerated, with no significant or new safety concerns identified. Data from both trials were published in The New England Journal of Medicine and based in part on the trial results, in December 2024 the journal Science named lenacapavir its 2024 “Breakthrough of the Year.”
Continued global regulatory filings and milestone partnerships for lenacapavir for PrEP
Gilead is executing a global access strategy informed by health advocates and organizations that prioritizes speed and enables the most efficient paths for regulatory review, approval of and access to twice-yearly lenacapavir for PrEP. Beyond approvals in the U.S. and EU, Gilead has also filed for regulatory review of twice-yearly lenacapavir for PrEP with authorities in Australia, Brazil, Canada, South Africa and Switzerland. Additionally, now that lenacapavir for PrEP has received approvals in the U.S. and the EU, Gilead is preparing filings in Argentina, Mexico and Peru.
Following the recent EU-Medicines for all (EU-M4all) positive opinion for lenacapavir for PrEP, Gilead intends to pursue submissions to national regulatory authorities in low- and middle-income countries (LMIC) utilizing the opinion to facilitate accelerated review timelines. This includes priority registrations covering 18 countries that represent 70% of the HIV burden of the 120 countries named in Gilead’s previously announced voluntary licensing agreements. The EU-M4all procedure also enables a streamlined assessment for World Health Organization (WHO) prequalification. Additionally, in July, Gilead announced a strategic partnership agreement with The Global Fund to Fight AIDS, Tuberculosis and Malaria to supply lenacapavir for PrEP for up to two million people in primarily low- and lower-middle-income countries, if approved.
For more information about Gilead’s access strategy for LMICs, see Gilead’s LMIC access page.
Lenacapavir for PrEP is not approved by any regulatory authority outside of the U.S. and the EU.
There is currently no cure for HIV or AIDS.
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