Gilead Seeks OK for Twice Yearly Lenacapavir

FDA has accepted for priority review a Gilead Sciences NDA for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, for use in preventing HIV as pre-exposure prophylaxis. The agency has set a review action target date of 6/19.

The submission is based on data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials. In PURPOSE 1 (NCT04994509), data showed twice-yearly lenacapavir demonstrated zero infections in those taking lenacapavir and 100% risk reduction and superiority compared to background HIV (bHIV) incidence in cisgender women, the company says. In PURPOSE 2 (NCT04925752), data showed that 99.9% of participants in the lenacapavir group did not acquire HIV infection, a 96% risk reduction in HIV infections, and superiority compared to bHIV in cisgender men and gender-diverse people. “In both trials, twice-yearly lenacapavir also demonstrated superiority of prevention of HIV infections when compared with once-daily oral Truvada…,” it adds.