The drug is already approved for HIV treatment
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FDA Approves Yeztugoas First Twice-Yearly Injectable HIV Prevention Option in the U.S.
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Clinical Trials Show Near-Perfect Efficacy With 99.9% of Participants Remaining HIV Negative
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Gilead Launches Broad Access Strategy to Ensure Coverage for Both Insured and Uninsured Patients
The U.S. Food and Drug Administration (FDA) has approved the drug Yeztugo (lenacapavir), a twice-yearly injectable medication from Gilead Sciences, Inc., for the prevention of HIV. The drug is currently approved for HIV treatment.
This makes Yeztugo the first and only twice-yearly option for pre-exposure prophylaxis (PrEP) available in the United States, offering a new tool to reduce the risk of sexually acquired HIV in adults and adolescents.
Yeztugo is a capsid inhibitor that has shown promise in clinical trials. The FDAs approval is based on compelling data from the Phase 3 PURPOSE 1 and PURPOSE 2 studies, where the medication demonstrated efficacy. Gilead said the drug achieved a 99.9% success rate.
Since the approval of the first PrEP treatment in 2012also developed by Gileadusage has remained stubbornly low. According to the Centers for Disease Control and Prevention, only 36% of people eligible for PrEP were prescribed it in 2022, with especially low access among women, Black and Hispanic communities, and residents of the U.S. South.
This could be the transformative PrEP option weve been waiting for, said Dr. Carlos del Rio of Emory University. A long-acting injectable helps tackle adherence issues and may reduce stigma for many who find daily oral medication difficult.
Access strategy
Gilead is rolling out a comprehensive access strategy to ensure Yeztugo is broadly available. For those with commercial insurance, the companys Advancing Access Co-Pay Savings Program may reduce out-of-pocket costs to as little as zero.
Uninsured patients who qualify can receive Yeztugo free of charge through the companys medication assistance program.
This is a historic day in the decades-long fight against HIV, said Daniel ODay, Gileads chairman and CEO. Yeztugo represents not only a scientific breakthrough but also a genuine opportunity to transform HIV prevention and help end the epidemic.
While Yeztugo is currently only approved in the United States, Gilead has initiated regulatory filings in several countries, including those in the EU, Canada, Brazil, South Africa, and Australia. Additional filings are planned for nations that recognize FDA approvals, including Argentina, Mexico, and Peru.
Posted: 2025-06-20 10:44:13
