The FDA could approve a new twice-yearly HIV prevention treatment this year

Preventing HIV infections could soon be as simple as two shots a year.

Gilead (GILD+2.11%) announced on Tuesday that the Food and Drug Administration (FDA) has accepted its new drug application for a twice-yearly injectable drug designed to prevent HIV. If approved, lenacapavir would be the first long-acting HIV-1 capsid inhibitor for pre-exposure prophylaxis (PrEP), a preventive treatment that lowers the risk of contracting HIV.

The FDA has granted the application a priority review, setting a target decision date of June 19, 2025. The submission follows the agency’s decision in October 2024 to grant lenacapavir Breakthrough Therapy Designation — a process aimed at speeding up the review of promising treatments for serious or life-threatening conditions.

“Today, we are one step closer to introducing the first-ever twice-yearly HIV prevention choice that could, if approved, help transform the landscape for individuals who need or want additional prevention options that better fit into their lives,” said Dietmar Berger, chief medical officer at Gilead, in a press release. “We’re excited about the potential of lenacapavir to make a real difference in HIV prevention in the U.S. and around the world, supporting the broader goal of ending the HIV epidemic for everyone, everywhere.”

The application is based on results from two phase 3 trials. In one, lenacapavir showed a 100% reduction in HIV infections among cisgender women, with zero participants contracting the virus. In the other, there were only two infections in the lenacapavir group, but 99.9% of participants remained HIV-free — representing a 96% risk reduction among cisgender men and gender-diverse individuals across diverse geographic regions.

The trials also found that lenacapavir was more effective at preventing HIV than Gilead’s older drug, Truvada, a once-daily pill.

Lenacapavir is already FDA-approved when used in combination with other antivirals for people with multi-drug resistant HIV.

Gilead stock rose 2% during intraday trading on Tuesday following the news. The company’s sales rose 6% to $28.8billion in 2024, Gilead reported last week.

The were an estimated 31,800 new HIV infections in the U.S. in 2022, according to the U.S. Centers for Disease Control and Prevention.