FDA accepts application for once-weekly oral Yeztugo, PDUFA date February 2, 2027

The FDA accepted Gilead's supplemental application for a once-weekly oral 300 mg lenacapavir tablet for HIV prevention, with a PDUFA action date of February 2, 2027. The filing relies on the PURPOSE 1 and PURPOSE 2 trials, which covered women, men and gender-diverse people. If approved it would be the first long-acting oral PrEP option.

• sNDA accepted; PDUFA action date February 2, 2027
• Once-weekly oral lenacapavir 300 mg tablet for PrEP
• Based on PURPOSE 1 and PURPOSE 2 trials
• Would be the first long-acting oral HIV prevention option if approved