Gilead's Lenacapavir Advances Toward FDA Approval for HIV Prevention

Gilead Sciences has received acceptance from the FDA for its new drug application (NDA) for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, intended for use as pre-exposure prophylaxis (PrEP). This marks a significant step toward providing a more convenient HIV prevention option, as current PrEP medications require daily intake. The FDA's priority review is set to conclude by June 19, 2025, following the drug's designation as a breakthrough therapy in October 2024. Clinical trials have indicated that lenacapavir offers substantial effectiveness in preventing HIV infections, showing 100% efficacy in one trial and a 96% reduction in another. Gilead is also pursuing marketing authorizations in Europe to expedite global access to this innovative treatment. If approved, lenacapavir could significantly improve adherence to HIV prevention strategies and contribute to the goal of ending the HIV epidemic worldwide.