Gilead announces FDA approves Yeztugo as twice-a-year HIV prevention option

Gilead (GILD) Sciences announced that the U.S. Food and Drug Administration has approved Yeztugo, or lenacapavir, the company’s injectable HIV-1 capsid inhibitor, as pre-exposure prophylaxis 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, Gilead noted. “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. 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,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. The company added: “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. 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 and EU-Medicines for all application with the European Medicines Agency, 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.”