FDA to Decide on First Twice-Yearly HIV Prevention Shot by June

Gilead's lenacapavir, a long-acting injectable drug, has shown up to 100% efficacy in trials and could transform HIV prevention if approved.

The FDA has accepted Gilead Sciences' application for lenacapavir, a twice-yearly injectable drug for HIV prevention, with a decision expected by June 19, 2025.
Lenacapavir demonstrated 96% to 100% efficacy in phase 3 trials, significantly reducing HIV infections among cisgender women, men, and gender-diverse individuals.
If approved, lenacapavir would be the first HIV pre-exposure prophylaxis (PrEP) option requiring only two shots per year, offering an alternative to daily pills or bimonthly injections.
The drug has already been FDA-approved for treating multi-drug resistant HIV but is not yet authorized for prevention use anywhere globally.
Gilead is pursuing regulatory approval in the U.S., Europe, and low-income countries, positioning lenacapavir as a potential breakthrough in global HIV prevention efforts.