June 19, 2025
The breakthrough drug may help end the HIV/AIDS epidemic, experts say.
The U.S. Food and Drug Administration approved an HIV prevention medication that has been proven highly effective in clinical trials.
Lenacapavir is an injectable treatment given twice a year to prevent HIV infection in adults and adolescents. In their June 17 announcement regarding FDA approval, Gilead Sciences, the drug’s manufacturer, stated that it will be marketed under the brand name Yeztugo.
“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, in a statement. “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.”
Lenacapavir is a capsid inhibitor, an antiviral medication that targets the HIV “capsid,” a protein shell that protects the virus’s genetic material and enzymes. The drug proved nearly 100% effective at preventing HIV in large trials last year. This could potentially interrupt the transmission of the virus that infects approximately 1.3 million people worldwide each year.
The company states that it plans to launch the drug in the U.S. swiftly and is seeking approval in countries that rely on FDA regulations for authorization, including Argentina, Mexico, and Peru. The company has also filed for regulatory approval of lenacapavir in Australia, Brazil, Canada, and South Africa.
Additionally, Gilead is working closely with U.S.-based insurers and healthcare providers to ensure coverage for the drug. Through its Advancing Access® Co-Pay Savings Program, the company will reduce out-of-pocket costs for uninsured patients. Visit Gilead’s website to learn more about Lenacapavir.
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