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# Gilead Seeks OK for Twice Yearly Lenacapavir
- URL: https://www.fdaweb.com/gilead-seeks-ok-for-twice-yearly-lenacapavir/
- Published: 2025-02-18T12:00:00.000Z
- Updated: 2026-09-14T14:53:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158679

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](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.gilead.com%2Fnews%2Fnews-details%2F2024%2Ffull-efficacy-and-safety-results-for-gilead-investigational-twice-yearly-lenacapavir-for-hiv-prevention-presented-at-aids-2024&esheet=54208662&newsitemid=20250217805274&lan=en-US&anchor=PURPOSE+1&index=1&md5=068aea3f6a70fbb34ee7923b3b42afde&ref=fdaweb.com) ([NCT04994509](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04994509&esheet=54208662&newsitemid=20250217805274&lan=en-US&anchor=NCT04994509&index=2&md5=7eaeb85d9d1fef425d811848ccb00d7e&ref=fdaweb.com)), 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](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.gilead.com%2Fnews%2Fnews-details%2F2024%2Fgilead-presents-full-purpose-2-data-results-for-twice-yearly-lenacapavir-for-hiv-prevention-at-hiv-glasgow&esheet=54208662&newsitemid=20250217805274&lan=en-US&anchor=PURPOSE+2&index=3&md5=fcef2e491d88a17746d53fdd1ad0af21&ref=fdaweb.com) ([NCT04925752](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04925752%3Fcond%3DHIV%26term%3Dpurpose%25202%26rank%3D1&esheet=54208662&newsitemid=20250217805274&lan=en-US&anchor=NCT04925752&index=4&md5=46f63e0f695af6136503945ab581f159&ref=fdaweb.com)), 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.