Gilead Sciences, Inc. announced the U.S. Food and Drug Administration accepted its supplemental New Drug Application for Yeztugo (lenacapavir) 300-mg tablet as a potential once-weekly oral formulation for the prevention of HIV as pre-exposure prophylaxis (PrEP). The FDA has assigned a Prescription Drug User Fee Act action date of February 2, 2027. The submission is supported by the robust and established clinical profile of lenacapavir for PrEP, based on results from the PURPOSE 1 and PURPOSE 2 trials, which demonstrated high efficacy across diverse global populations, including cisgender women, cisgender men and gender-diverse people.

Lenacapavir oral tablets are already approved for use within the Yeztugo regimen as an initial loading dose and as a bridge therapy when administration of the every-six-month injections are delayed. If approved, once-weekly oral Yeztugo could become the first long-acting oral PrEP option. Once-weekly oral lenacapavir for PrEP is investigational and not approved anywhere globally.

There is currently no cure for HIV or AIDS. Lenacapavir is approved in multiple countries as pre-exposure prophylaxis to reduce the risk of sexually acquired HIV in adults and adolescents who are at risk of HIV acquisition. Lenacapavir is also approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals.

The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead?s HIV prevention and treatment research program.

Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. The journal Science named lenacapavir its 2024 ?Breakthrough of the Year.? Yeztugo (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 in adults and adolescents (=35kg) who are at risk for HIV-1 acquisition.

Individuals must have a negative HIV-1 test prior to initiating Yeztugo. BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION. Individuals must be tested for HIV-1 infection prior to initiating Yeztugo, and with each subsequent injection of Yeztugo, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection.

Drug-resistant HIV-1 variants have been identified with use of Yeztugo by individuals with undiagnosed HIV-1 infection.