Gilead Sciences: FDA accepts GILEAD application for once-weekly oral HIV prevention pill

Gilead Sciences (NASDAQ: GILD) announced that the U.S. Food and Drug Administration has accepted its supplemental New Drug Application for Yeztugo (lenacapavir) as a once-weekly oral tablet for HIV pre-exposure prophylaxis (PrEP). The FDA has set a PDUFA action date of February 2, 2027.

The application covers a 300-mg oral tablet taken once weekly. If approved, Gilead claims the formulation would be the first long-acting oral PrEP option. The drug is currently not approved in any oral once-weekly form anywhere globally.

The submission is supported by data from the PURPOSE 1 and PURPOSE 2 clinical trials, which evaluated lenacapavir for PrEP across populations including cisgender women, cisgender men, and gender-diverse people.

Lenacapavir is already approved in the U.S. as a twice-yearly injectable PrEP under the Yeztugo brand, with oral tablets currently authorized only as an initial loading dose or as a bridge therapy when scheduled injections are delayed.

Gilead Chief Medical Officer Dietmar Berger said in a statement: "HIV prevention is not one-size-fits-all, and if approved, once-weekly oral Yeztugo would provide more choice for people who need or want PrEP."

The FDA's acceptance of the application does not guarantee approval. The once-weekly oral formulation remains investigational pending the agency's review.

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