Gilead Sciences announced the FDA accepted its supplemental New Drug Application for Yeztugo (lenacapavir). The application covers an investigational 300-mg oral tablet for once-weekly HIV pre-exposure prophylaxis (PrEP).
The FDA set a target action date of February 2, 2027, under the Prescription Drug User Fee Act. If approved, this formulation would become the first long-acting oral PrEP option available to the public.
The submission relies on data from the PURPOSE 1 and PURPOSE 2 clinical trials. These studies demonstrated high efficacy for the drug in preventing HIV infection.
Yeztugo is currently approved as a twice-yearly injectable for PrEP. This new oral version aims to provide an alternative to existing daily pills.