{"id":61771,"date":"2025-08-26T10:05:25","date_gmt":"2025-08-26T08:05:25","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/european-commission-authorizes-twice-yearly-yeytuo-lenacapavir-for-hiv-prevention\/"},"modified":"2025-08-26T10:05:25","modified_gmt":"2025-08-26T08:05:25","slug":"european-commission-authorizes-twice-yearly-yeytuo-lenacapavir-for-hiv-prevention","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/european-commission-authorizes-twice-yearly-yeytuo-lenacapavir-for-hiv-prevention\/","title":{"rendered":"European Commission Authorizes Twice-Yearly Yeytuo\u00ae (Lenacapavir) for HIV Prevention"},"content":{"rendered":"
\n

\n\u2013 Yeytuo\u00ae <\/sup>is the First and Only European Commission (EC)-Authorized HIV PrEP Option Offering 6 Months of Protection \u2013<\/i><\/b><\/p>\n

\n\u2013 Accelerated EC Decision Comes After U.S. FDA Approval in June \u2013<\/i><\/b><\/p>\n

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has granted marketing authorization for Yeytuo\u00ae<\/sup> (lenacapavir)\u2014the company\u2019s twice-yearly injectable HIV-1 capsid inhibitor\u2014for 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 <\/sup>is the first and only twice-yearly PrEP option to be approved for use in the European Union\u2019s 27 member states, as well as Norway, Iceland and Liechtenstein.<\/p>\n

<\/a>
<\/a><\/p>\n

\nThe marketing authorization application (MAA) was reviewed under an accelerated timeline based on the assessment by the European Medicines Agency\u2019s (EMA) Committee for Medicinal Products for Human Use (CHMP) that twice-yearly Yeytuo <\/sup>is a product of major interest for public health. In July, the CHMP adopted a positive opinion<\/a> 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.<\/p>\n

\n\u201cYeytuo\u2019s 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,\u201d said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences. \u201cThis 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.\u201d<\/p>\n

\nThe EC authorization follows approval by the U.S. Food and Drug Administration (FDA) in June<\/a>, as well as the issuance of guidelines by the World Health Organization (WHO) in July<\/a> that recommended twice-yearly lenacapavir as an additional PrEP option for HIV prevention.<\/p>\n

\n\u201cWith around 25,000 new HIV diagnoses in the EU and European Economic Area every year, it\u2019s clear that current prevention options are not working for everyone who needs or wants them, especially among vulnerable populations,\u201d said Jean-Michel Molina, MD, Universit\u00e9 Paris Cit\u00e9, Professor of Infectious Diseases and Head of the Infectious Diseases Department at the Saint-Louis and Lariboisi\u00e8re Hospitals. \u201cYeytuo\u2019s novel twice-yearly dosing schedule and high efficacy could be the transformative HIV prevention option in Europe we\u2019ve been waiting for to help us reduce new infections and make real progress toward ending the HIV epidemic.\u201d<\/p>\n

\nEC authorization of Yeytuo <\/sup>is supported by efficacy and safety data from two Phase 3 trials<\/b><\/p>\n

\nThe EC authorization of Yeytuo <\/sup>was supported by data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead. In the PURPOSE 1 trial<\/a> (NCT04994509<\/a>), 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\u00ae<\/sup> (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F\/TDF) <\/i>in cisgender women in sub-Saharan Africa. In the PURPOSE 2 trial<\/a> (NCT04925752<\/a>), 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) <\/i>and was generally well-tolerated, with no significant or new safety concerns identified.<\/i> Data from both trials were published in The New England Journal of Medicine<\/i> and based in part on the trial results, in December 2024 the journal Science<\/i> named lenacapavir its 2024 \u201cBreakthrough of the Year.\u201d<\/p>\n

\nContinued global regulatory filings and milestone partnerships for lenacapavir for PrEP<\/b><\/p>\n

\nGilead 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<\/a>, 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.<\/p>\n

\nFollowing the recent EU-Medicines for all (EU-M4all) positive opinion for lenacapavir for PrEP<\/a>, 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\u2019s previously announced<\/a> 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<\/a> 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.<\/p>\n

\nFor more information about Gilead\u2019s access strategy for LMICs, see Gilead\u2019s LMIC access page<\/a>.<\/p>\n

\nLenacapavir for PrEP is not approved by any regulatory authority outside of the U.S. and the EU.<\/p>\n

\nThere is currently no cure for HIV or AIDS.<\/p>\n

\nAbout Lenacapavir<\/span><\/b><\/p>\n

\nLenacapavir is approved in multiple countries as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents who are at risk of HIV acquisition. Lenacapavir is also approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals.<\/p>\n

\nThe multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro <\/i>to other existing drug classes.<\/p>\n

\nLenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead\u2019s HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. The journal Science <\/i>named lenacapavir its 2024 \u201cBreakthrough of the Year.\u201d<\/p>\n

\nEU Indication for Yeytuo\u00ae<\/sup><\/span><\/b><\/p>\n

\nYeytuo\u00ae<\/sup><\/b> injection is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV-1 acquisition risk weighing at least 35kg.<\/p>\n

\nU.S. Indication for Yeztugo<\/span>\u00ae<\/sup><\/span><\/b><\/p>\n

\nYeztugo\u00ae<\/sup><\/b> (lenacapavir) injection, 463.5 mg\/1.5 mL, is indicated for pre\u2011exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (\u226535kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo.<\/p>\n

\nU.S. Important Safety Information for Yeztugo<\/span><\/b><\/p>\n

\nBOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION<\/b><\/p>\n