European Medicines Agency Validates Gilead’s Marketing Authorization Application and EU-Medicines for All Application for Twice-Yearly Lenacapavir for HIV Prevention
Gilead Sciences (GILD) announced that the European Medicines Agency (EMA) has validated for parallel accelerated review its Marketing Authorization Application (MAA) and EU-Medicines for all (EU-M4all) application for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor for HIV prevention.
The applications are supported by data from Phase 3 trials: PURPOSE 1 showed 100% risk reduction in cisgender women, while PURPOSE 2 demonstrated 99.9% effectiveness with a 96% risk reduction among cisgender men and gender-diverse people. Both trials proved superiority compared to daily oral Truvada.
The EU MAA will cover all 27 EU Member States plus Norway, Iceland, and Liechtenstein. The EU-M4all application aims to facilitate expedited reviews in low and lower-middle-income countries. This follows the FDA's acceptance of Gilead's New Drug Applications for lenacapavir under priority review.
Gilead Sciences (GILD) ha annunciato che l'Agenzia Europea per i Medicinali (EMA) ha convalidato per una revisione accelerata parallela la sua Domanda di Autorizzazione all'Immissione in Commercio (MAA) e la domanda EU-Medicines for all (EU-M4all) per lenacapavir, un inibitore della capsula dell'HIV-1 iniettabile due volte all'anno per la prevenzione dell'HIV.
Le domande sono supportate da dati provenienti da studi di Fase 3: lo studio PURPOSE 1 ha mostrato una riduzione del rischio del 100% nelle donne cisgender, mentre lo studio PURPOSE 2 ha dimostrato un'efficacia del 99,9% con una riduzione del rischio del 96% tra gli uomini cisgender e le persone di genere diverso. Entrambi gli studi hanno dimostrato superiorità rispetto al Truvada orale giornaliero.
La MAA dell'UE coprirà tutti i 27 Stati membri dell'UE più Norvegia, Islanda e Liechtenstein. La domanda EU-M4all mira a facilitare revisioni accelerate nei paesi a basso e medio-basso reddito. Questo segue l'accettazione da parte della FDA delle Nuove Domande di Farmaci di Gilead per lenacapavir sotto revisione prioritaria.
Gilead Sciences (GILD) anunció que la Agencia Europea de Medicamentos (EMA) ha validado para una revisión acelerada paralela su Solicitud de Autorización de Comercialización (MAA) y la solicitud EU-Medicines for all (EU-M4all) para lenacapavir, un inhibidor de la cápside del VIH-1 inyectable dos veces al año para la prevención del VIH.
Las solicitudes están respaldadas por datos de ensayos de Fase 3: el ensayo PURPOSE 1 mostró una reducción del riesgo del 100% en mujeres cisgénero, mientras que el PURPOSE 2 demostró una efectividad del 99.9% con una reducción del riesgo del 96% entre hombres cisgénero y personas de género diverso. Ambos ensayos demostraron superioridad en comparación con el Truvada oral diario.
La MAA de la UE cubrirá los 27 Estados miembros de la UE más Noruega, Islandia y Liechtenstein. La solicitud EU-M4all tiene como objetivo facilitar revisiones aceleradas en países de ingresos bajos y medios-bajos. Esto sigue la aceptación por parte de la FDA de las Nuevas Solicitudes de Medicamentos de Gilead para lenacapavir bajo revisión prioritaria.
길리어드 사이언스(GILD)는 유럽 의약품청(EMA)이 레나카파비르에 대한 마케팅 승인 신청(MAA) 및 EU-Medicines for all (EU-M4all) 신청서를 병행 가속 검토를 위해 검증했다고 발표했습니다. 레나카파비르는 HIV 예방을 위한 연 2회 주사 가능한 HIV-1 캡시드 억제제입니다.
신청서는 3상 시험의 데이터를 지원합니다: PURPOSE 1은 시스젠더 여성에서 100%의 위험 감소를 보여주었고, PURPOSE 2는 시스젠더 남성과 성별 다양성이 있는 사람들 사이에서 96%의 위험 감소와 함께 99.9%의 효과를 입증했습니다. 두 시험 모두 매일 복용하는 트루바다에 비해 우수성을 입증했습니다.
EU MAA는 27개 EU 회원국과 노르웨이, 아이슬란드, 리히텐슈타인을 포함합니다. EU-M4all 신청은 저소득 및 중저소득 국가에서의 신속한 검토를 촉진하는 것을 목표로 합니다. 이는 FDA가 레나카파비르에 대한 길리어드의 신약 신청을 우선 검토로 수용한 데 따른 것입니다.
Gilead Sciences (GILD) a annoncé que l'Agence Européenne des Médicaments (EMA) a validé pour une révision accélérée parallèle sa Demande d'Autorisation de Mise sur le Marché (MAA) et sa demande EU-Medicines for all (EU-M4all) pour lenacapavir, un inhibiteur de la capsule du VIH-1 injectable deux fois par an pour la prévention du VIH.
Les demandes sont soutenues par des données provenant d'essais de Phase 3 : l'essai PURPOSE 1 a montré une réduction du risque de 100 % chez les femmes cisgenres, tandis que le PURPOSE 2 a démontré une efficacité de 99,9 % avec une réduction du risque de 96 % chez les hommes cisgenres et les personnes de genre divers. Les deux essais ont prouvé leur supériorité par rapport au Truvada oral quotidien.
La MAA de l'UE couvrira les 27 États membres de l'UE ainsi que la Norvège, l'Islande et le Liechtenstein. La demande EU-M4all vise à faciliter les révisions accélérées dans les pays à faible et moyen revenu. Cela fait suite à l'acceptation par la FDA des Nouvelles Demandes de Médicaments de Gilead pour lenacapavir dans le cadre d'une révision prioritaire.
Gilead Sciences (GILD) hat angekündigt, dass die Europäische Arzneimittel-Agentur (EMA) ihren Antrag auf Marktzulassung (MAA) und den Antrag EU-Medicines for all (EU-M4all) für Lenacapavir, einen halbjährlich injizierbaren HIV-1-Capsid-Inhibitor zur HIV-Prävention, für eine parallele beschleunigte Prüfung validiert hat.
Die Anträge werden durch Daten aus Phase-3-Studien unterstützt: Die Studie PURPOSE 1 zeigte eine Risikominderung von 100 % bei cisgeschlechtlichen Frauen, während PURPOSE 2 eine Wirksamkeit von 99,9 % mit einer Risikominderung von 96 % bei cisgeschlechtlichen Männern und geschlechterdiversen Personen nachwies. Beide Studien bewiesen die Überlegenheit im Vergleich zu täglich oral eingenommenem Truvada.
Die EU-MAA wird alle 27 EU-Mitgliedstaaten sowie Norwegen, Island und Liechtenstein abdecken. Der Antrag EU-M4all zielt darauf ab, beschleunigte Prüfungen in einkommensschwachen und mittleren Ländern zu erleichtern. Dies folgt der Annahme der FDA von Gileads Neuen Arzneimittelanträgen für Lenacapavir unter priorisierter Prüfung.
- Phase 3 PURPOSE 1 trial showed 100% risk reduction in HIV prevention
- Phase 3 PURPOSE 2 trial demonstrated 99.9% effectiveness with 96% risk reduction
- EMA granted accelerated assessment review status
- FDA accepted applications under priority review
- Potential expansion to low and lower-middle-income countries through EU-M4all
- Lenacapavir for HIV prevention is not yet approved in any country
- Regulatory approval process still pending with potential risks of delays or rejection
Insights
The EMA's validation of lenacapavir for HIV prevention marks a pivotal development in Gilead's HIV franchise evolution. The parallel accelerated assessment of both the standard MAA and EU-M4all applications demonstrates exceptional regulatory efficiency and highlights the product's potential public health impact. The EU-M4all pathway is particularly strategic, as it could expedite access in low- and lower-middle-income countries, where HIV prevention needs are often greatest.
The PURPOSE trials' data is remarkably robust, with
Lenacapavir's multi-stage mechanism of action, with no known cross-resistance to existing drug classes, provides a strong scientific foundation for long-term efficacy. This characteristic, combined with the convenient dosing schedule, could position it as a preferred option in both high-income markets and resource- settings.
The parallel regulatory submissions in major markets, combined with the EU-M4all strategy, suggest a well-orchestrated global access approach. This could accelerate Gilead's market penetration while fulfilling critical public health needs. The recognition by Science Magazine as "Breakthrough of the Year" further validates the potential impact of this innovation on global HIV prevention efforts.
– One Application Seeks European Commission Authorization; Other Application Would Facilitate Availability in Low- and Lower-Middle-Income Countries –
– Both Applications Will Be Assessed in Parallel Under Accelerated Assessment Review Timeline Based on Potential Public Health Interest in Lenacapavir for HIV Prevention –
– EMA Validation Follows Acceptance of
Based on the assessment of EMA’s Committee for Medicinal Products for Human Use (CHMP) that twice-yearly lenacapavir for prevention is a product of major interest for public health and therapeutic innovation, both applications will be assessed under an accelerated assessment review timeline.
The EU MAA will be reviewed by the CHMP under the centralized licensing procedure for all 27 Member States of the European Union, as well as
The EMA validation follows the announcement last week that the
“Achieving another key regulatory milestone so soon after the
The EMA applications are supported by data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead. In PURPOSE 1 (NCT04994509), data showed twice-yearly lenacapavir demonstrated zero infections in the lenacapavir group and
Gilead is executing an access strategy, informed by global health advocates and organizations, that prioritizes speed and enables the most efficient paths for the regulatory review, approval of and access to lenacapavir for PrEP in regions around the world.
The use of lenacapavir for the prevention of HIV is investigational and is not approved anywhere globally.
There is currently no cure for HIV or AIDS.
About Lenacapavir
Lenacapavir is approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established.
The 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 to other existing drug classes.
Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s 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.
About the PURPOSE Program
Gilead’s landmark PURPOSE program is the most comprehensive and diverse HIV prevention trial program ever conducted. The program comprises five HIV prevention trials around the world that are focused on innovation in science, trial design, community engagement and health equity.
The PURPOSE trials are evaluating the safety and efficacy of an investigational, twice-yearly injectable medicine, lenacapavir, to reduce the chance of getting HIV. The Phase 2 and 3 program, consisting of PURPOSE 1-5, is assessing the potential of lenacapavir to help a diverse range of people around the world who could benefit from PrEP.
More information about the PURPOSE program, including individual trial descriptions, populations and locations, can be found at www.purposestudies.com.
About Gilead HIV
For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 12 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people.
Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving lenacapavir (such as PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including the New Drug Applications seeking FDA approval and the MAA and EU-M4all seeking EMA approval of lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; Gilead’s ability to effectively manage the access strategy relating to lenacapavir, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as filed with the
Gilead and the Gilead logo, Truvada, and Truvada for PrEP are registered trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
View source version on businesswire.com: https://www.businesswire.com/news/home/20250223971731/en/
Ashleigh Koss, Media
public_affairs@gilead.com
Jacquie Ross, Investors
investor_relations@gilead.com
Source: Gilead Sciences, Inc.
FAQ
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