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 transmitted HIV infection in adults and adolescents weighing at least 35 kg. This makes it the first and only twice-yearly option available in the U.S. 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 real opportunity to end the HIV epidemic," said Daniel O'Day, Chairman and CEO of Gilead Sciences. "This drug only needs to be administered twice a year and has shown remarkable results in clinical trials. It could revolutionize HIV prevention. The scientists at Gilead have made it their life's work to defeat HIV. With the FDA approval of Yeztugo and in collaboration with our many partners, we can now help make this goal a reality."
The first PrEP drug, also developed by Gilead, was approved in the US 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 one in three (36%) people in the U.S. who met the CDC's eligibility criteria for PrEP were prescribed some form of PrEP. CDC data show that not all populations in the U.S. are yet using PrEP at a rate that could end transmission of the virus at the population level. There are particular gaps among women, Blacks/African Americans and Hispanics/Latinos, as well as people in the U.S. South. The data also show that barriers such as adherence issues, stigma, and low awareness of existing PrEP options - among both healthcare providers and consumers - contribute to this low utilization of PrEP in many populations. The potential impact of this limited uptake, adherence and access is underscored by the fact that more than 100 people were diagnosed with HIV every day in the US in 2023.
Yeztugo could be the breakthrough PrEP option we've been waiting for - it offers the potential to increase PrEP uptake and persistence and is a powerful new tool in our goal to end the HIV epidemic," said Dr. Carlos del Rio, 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 significantly reduce important barriers such as adherence and stigma that individuals may face with more frequent PrEP dosing regimens, particularly daily oral PrEP. We also know that studies have shown that many people who need or want PrEP prefer less frequent dosing."
The FDA approval of Yeztugo is supported by high efficacy and proven safety data in two clinical studies
FDA approval of Gilead's marketing applications for Yeztugo was supported by data from Gilead's Phase 3 PURPOSE 1 and PURPOSE 2 studies. In the PURPOSE 1 study ( NCT04994509 ), data from the primary analysis showed that Yeztugo administered subcutaneously twice yearly in 2.134 participants in the Yeztugo group had no HIV infections, reduced HIV infections by 100% and proved superior in preventing HIV infections compared to once-daily oral administration of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; F/TDF) in cisgender women in sub-Saharan Africa. In the PURPOSE 2 study ( NCT04925752 ), there were two HIV infections among the 2,179 participants in the group receiving Yeztugo subcutaneously twice a year. This showed that 99.9% of participants in the Yeztugo group did not become infected with HIV and that prevention of HIV infection was superior to once-daily oral Truvada. This was demonstrated in a broad and geographically diverse range of cisgender men and sexually diverse individuals. In both studies, Yeztugo was also shown to be superior in preventing HIV infection compared to background HIV incidence (bHIV) and was generally well tolerated, with no significant or new safety concerns identified . Data from both studies were published in the New England Journal of Medicine and, based in part on the study results, the journal Science recognized lenacapavir as its "Breakthrough of the Year 2024" in December 2024.
Yeztugo received FDA approval under a priority review process. In addition, Yeztugo was granted breakthrough therapy status in October 2024. This is intended to accelerate the development and testing of new drugs that may represent a significant improvement over available therapies.
Gilead's US access strategy for Yeztugo is designed to enable broad adoption and availability to individuals with and without insurance coverage
In the U.S., Gilead is working closely with insurers, health systems and other payers to ensure broad insurance coverage for Yeztugo. In addition, Gilead's Advancing Access Co-Pay Savings Program reduces co-payments for eligible privately insured individuals to as low as zero dollars.
Gilead is also committed to ensuring that people without health insurance in the U.S. can benefit from Yeztugo. Eligible individuals receive Yeztugo at no cost through Gilead's Advancing Access medication assistance program.
Additional regulatory applications are currently being submitted in various countries around the world.
Outside the U.S., Gilead is pursuing an access strategy supported by global health advocates and organizations that prioritizes speed and enables the most efficient pathways for regulatory review, approval and access to twice-yearly lenacapavir for PrEP. Gilead has submitted a Marketing Authorization Application (MAA) and an EU Medicine for All (EU-M4all) to the European Medicines Agency (EMA), both of which have been validated by the EMA and are being reviewed under an accelerated assessment period. Gilead has also filed for regulatory approval of twice-yearly lenacapavir for PrEP with authorities in Australia, Brazil, Canada and South Africa. Now that Yeztugo has received FDA approval, Gilead is also preparing additional filings in countries that rely on FDA approval for regulatory submissions, including Argentina, Mexico and Peru. Gilead will continue to keep you informed of new applications for approval.
Lenacapavir for HIV prevention is not approved by any regulatory authority outside the United States.
There is currently no cure for HIV or AIDS.
Below is the U.S. indication and important safety information for Yeztugo, including the framed warning.
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