Foster City, CA– The U.S. Food and Drug Administration has approved Gilead Sciences’ Yeztugo® (lenacapavir) as the first and only HIV prevention treatment offering protection with just two injections per year. The long-acting injectable is now available as a pre-exposure prophylaxis (PrEP) option for adults and adolescents weighing at least 35 kg, marking a significant advancement in the fight to end the HIV epidemic.
The approval is based on data from Gilead’s Phase 3 PURPOSE 1 and PURPOSE 2 clinical trials, which showed that more than 99.9% of participants who received Yeztugo remained HIV-negative. In both trials, lenacapavir demonstrated superior efficacy to once-daily oral Truvada® and proved generally well-tolerated with no new safety concerns identified.
“This is a historic day in the decades-long fight against HIV,” said Gilead Chairman and CEO Daniel O’Day. “Yeztugo is one of the most important scientific breakthroughs of our time, offering a powerful and convenient new option that could transform HIV prevention.”
Yeztugo’s approval comes as health authorities continue to address the underutilization of PrEP in the U.S. According to CDC data, only 36% of eligible individuals were prescribed a form of PrEP in 2022, with significant disparities across racial, gender, and geographic lines. Experts hope Yeztugo’s less frequent dosing schedule will help overcome barriers related to adherence, stigma, and awareness.
“A twice-yearly injection could be the transformative PrEP option we’ve been waiting for,” said Dr. Carlos del Rio of Emory University. “This could significantly increase uptake and persistence among those most at risk.”
Gilead is working with insurers and healthcare providers to ensure broad access to Yeztugo. The company’s co-pay savings and medication assistance programs will aim to minimize out-of-pocket costs and provide free access to uninsured eligible individuals.
Global regulatory filings for lenacapavir as PrEP are underway in the EU, Australia, Brazil, Canada, South Africa, and several Latin American countries, with more expected to follow now that the drug has received FDA approval.
Yeztugo is not a cure for HIV or AIDS but offers a major step forward in prevention, with the potential to expand protection to populations historically underserved by existing PrEP options.
