The Food and Drug Administration (FDA) has approved accelerated review for the use of lenacapavir, a twice-yearly injectable drug, as an HIV pre-exposure prophylaxis (PrEP) preventive. Lenacapavir was approved in 2022 as an HIV treatment medication "for use in heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are experiencing virologic failure."
Under its New Drug Application, the "FDA will review the applications under priority review and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 19, 2025," according to a 2/18/25 news release from the manufacturer, Gilead. (Learn more about FDA's Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review processes.)
As a result of data on lenacapavir's nearly 100% efficacy as a PrEP regimen, FDA granted lenacapavir Breakthrough Therapy Designation in October 2024, establishing the basis for expedited review of its use as a substantial improvement over existing therapy. In December 2024, Science Magazine designated lenacapavir as 2024 Breakthrough of the Year.
Read our blog, PrEP Policies and Programs Help End the HIV Epidemic and see our resources on PrEP, featuring the National HIV PrEP Curriculum.