Lenacapavir Sodium

WASHINGTON, DC, UNITED STATES, June 19, 2025 / EINPresswire.com / -- The U.S. Food and Drug Administration approval of Lenacapavir as a twice-yearly injectable PrEP marks a breakthrough in HIV prevention, especially for communities hardest hit by the epidemic—Black and Latino gay and bisexual men, Black women, transgender people, those experiencing homelessness, and others facing systemic barriers to care. This long-acting option offers a lifeline for those unable to adhere to daily pills, providing greater privacy and ease of use. But innovation without access is not equity. “This is a remarkable step forward, but science alone doesn’t save lives—access does,” said Paul Kawata, Executive Director of NMAC . “Without a strong HIV prevention infrastructure, long-acting PrEP like Lenacapavir won’t reach the communities who need it most. ” As the federal government threatens to dismantle HIV prevention infrastructure through budget cuts and Medicaid rollbacks, it’s more urgent than ever to ensure Lenacapavir is affordable, accessible, and delivered in trusted, community-based settings. No one should be denied protection because of their race, income, gender identity, or zip code. NMAC calls on leaders at every level to act with urgency and purpose—health equity cannot wait. Long-acting PrEP like Lenacapavir must be more than a medical milestone; it must be a tool for justice. We remain steadfast in our commitment to work alongside policymakers, providers, and the communities most affected by HIV to turn this breakthrough into broad, equitable access. The science exists—now it’s time to mobilize, to advocate, and to ensure no one is left behind. About NMAC: Launched in 1987 during the early years of the HIV/AIDS crisis, NMAC is a national HIV organization that offers capacity building, leadership development, policy and advocacy, and public engagement to end the HIV epidemic among communities most impacted in the United States. We convene Biomedical HIV Prevention Summit - the nation’s largest gathering focused on PrEP for HIV prevention and the U.S. Conference on HIV/AIDS - the nation’s largest gathering for community building and advocacy mobilization. NMAC Press Contact Pavni Guharoy NMAC +1 240-372-8394 email us here Visit us on social media: LinkedIn Instagram Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

– Approval Based on Phase 3 PURPOSE 1 and PURPOSE 2 Data that Showed ≥ 99.9% of Participants Remained HIV Negative on Twice-Yearly Injectable Yeztugo – – Yeztugo, Nearly 20 Years in the Making, Represents a Major Breakthrough in the Fight Against HIV – FOSTER CITY, CA, USA I June 18, 2025 I Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo ® (lenacapavir)—the company’s injectable HIV-1 capsid inhibitor—as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the United States for people who need or want PrEP. Data show that ≥99.9% of participants who received Yeztugo in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative. “This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. “This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention. Gilead scientists have made it their life’s work to end HIV and now, with the FDA approval of Yeztugo and in collaboration with our many partners, we can help to make that goal a reality.” The first PrEP medication, which was also developed by Gilead, was approved in the U.S. in 2012. However, data from the Centers for Disease Control and Prevention (CDC) show that, in 2022 (the most recent year with available data), only about 1 in 3 (36%) people in the U.S. who met the CDC’s eligibility criteria for PrEP were prescribed a form of PrEP. CDC data show that all populations in the U.S. are not yet using PrEP at rates that could end transmission of the virus at the population level, with particular gaps for women, Black/African American and Hispanic/Latino people, and people in the U.S. South. Data also show that barriers including adherence challenges, stigma and low awareness of existing PrEP options—by both healthcare providers and consumers—contribute to this low uptake of PrEP across multiple populations. The potential impact of this limited uptake, adherence and access is underscored by the fact that, in 2023, more than 100 people were diagnosed with HIV every day in the U.S. “Yeztugo could be the transformative PrEP option we’ve been waiting for—offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,” said Carlos del Rio, MD, Distinguished Professor of Medicine in the Division of Infectious Diseases at Emory University School of Medicine and Co-Director of the Emory Center for AIDS Research in Atlanta. “A twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face. We also know that, in research, many people who need or want PrEP preferred less frequent dosing.” FDA approval of Yeztugo is supported by high efficacy and demonstrated safety data in two clinical trials The FDA approval of Gilead’s New Drug Applications (NDAs) for Yeztugo 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 twice-yearly subcutaneous Yeztugo demonstrated zero HIV infections among 2,134 participants in the Yeztugo group, 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 ), there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous Yeztugo group, demonstrating 99.9% of participants in the Yeztugo group 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, Yeztugo also 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.” Yeztugo received FDA approval under Priority Review. Additionally, in October 2024, Yeztugo was granted Breakthrough Therapy Designation, which is intended to expedite the development and review of new drugs that may demonstrate substantial improvement over available therapy. Gilead’s U.S. access strategy for Yeztugo is designed to enable broad uptake and availability for individuals with and without insurance coverage In the U.S., Gilead is working closely with insurers, healthcare systems and other payers with the goal of ensuring broad insurance coverage for Yeztugo. Additionally, for eligible commercially insured individuals with commercial insurance, Gilead’s Advancing Access ® Co-Pay Savings Program will reduce out-of-pocket costs to as little as zero dollars. Gilead is also committed to helping to ensure that people without insurance in the U.S. will be able to benefit from Yeztugo. For those who are eligible, Gilead’s Advancing Access medication assistance program will provide Yeztugo free of charge. Additional regulatory filings are underway in countries around the world Outside of the U.S., 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 twice-yearly lenacapavir for PrEP. Gilead has submitted a marketing authorization application (MAA) and EU-Medicines for all (EU-M4all) application with the European Medicines Agency (EMA), both of which the EMA has validated and will review under an accelerated assessment timeline. Gilead has also filed for regulatory approval for twice-yearly lenacapavir for PrEP with authorities in Australia, Brazil , Canada and South Africa . Additionally, now that Yeztugo has received FDA approval, Gilead is preparing additional filings in countries that rely on FDA approval for regulatory submission, including Argentina, Mexico and Peru. Gilead will continue to share updates on additional regulatory filings. Lenacapavir for HIV prevention is not approved by any regulatory authority outside of the United States. There is currently no cure for HIV or AIDS. Please see below for the U.S. Indication and Important Safety Information for Yeztugo, including Boxed Warning. About Lenacapavir Lenacapavir is approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals. Lenacapavir is also approved in the United States to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg who are at risk of HIV acquisition. 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. The journal Science named lenacapavir its 2024 “Breakthrough of the Year.” U.S. Indication for Yeztugo Yeztugo (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (>35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo. 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 13 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. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. SOURCE: Gilead Sciences