On February 18, Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) had accepted its submission.lenacapavirNew Drug Application (NDA) for the company's twice-yearly injectable HIV-1 capsid inhibitor for HIV prevention as pre-exposure prophylaxis (PrEP).The US FDA will review the priority review application and has set the PDUFA goal date for June 19, 2025. This comes after the US FDA granted the designation in October 2024.lenacApavir is used forFollowing the Breakthrough Therapy Designation, a new NDA was accepted. The Breakthrough Therapy Designation process aims to expedite the development and regulatory review of investigational treatments for serious or life-threatening diseases, which, based on preliminary clinical evidence, have the potential to significantly improve clinical outcomes compared to existing therapies.Dietmar Berger, MD, Chief Medical Officer of Gilead Sciences, said:"Today, we are one step closer to launching the first-ever twice-yearly HIV prevention option, which, if approved, could help transform the landscape for those who need or want additional prevention options that better suit their lives. We arelenacapavirExcited about the potential to play a real role in HIV prevention in the United States and around the world, supporting the broader goal of ending the HIV epidemic for everyone, everywhere.The new listing application is based on Phase 3 conducted by Gilead Sciences.PURPOSE 1 AndPURPOSE 2Data of the trial. InPURPOSE 1(NCT04994509), the data show that twice a yearlenacapavirInlenacapavirThe group showed zero infections, and compared with the background HIV incidence (bHIV), the risk of investigational use of HIV prevention in cisgender women was reduced by 100% and demonstrated superiority.PURPOSE 2In (NCT04925752), there were two cases of HIV infection in the lenacapavir group, indicatinglenacapavirGroup 99.9% of participants remained uninfected with HIV, reducing the risk of HIV infection by 96%, showing advantages over bHIV in a broad and geographically diverse population of cisgender men and transgender individuals. In both trials, compared to daily oral administration of Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF), twice-yearly...lenacapavirIt also demonstrated superiority in preventing HIV infection and was generally well-tolerated, with no significant or new safety issues identified. Based in part on these trial results, *Science* magazine named lenacapavir the 2024 "Breakthrough of the Year" in December 2024.Gilead is implementing an access strategy informed by global health advocates and organizations, which prioritizes speed and serves communities around the world in need of PrEP.lenacapavirregulatory review, approval, and access provide the most effective pathway. As part of this strategy, earlier this year, Gilead Sciences submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and a European Union-wide Medicines for All application (EU-M4all).lenacapavirFor PrEP. The EU-M4al application aims to help promote access to PrEP in low-income and lower-middle-income countries.lenacapavirThrough the EU-M4all program, the national regulatory authorities in these regions can use the EU's opinions to expedite the review process, potentially accelerating...lenacapavirFor PrEP access.As discussions with regulatory authorities progress, updates will be shared.lenacapavirLatest Status of Regulatory Documents for PrEP.UselenacapavirPreventing HIV is a research that has not been approved anywhere in the world. The U.S. FDA has not yet determined the safety and effectiveness of this usage.There is currently no cure for HIV or AIDS.Follow the official account below to see the world!
