Shots:
- The US FDA has accepted & granted priority review to the NDA of lenacapavir (HIV-1 capsid inhibitor) for PreP in individuals at risk of HIV (PDUFA: Jun 19, 2025); MAA & EU-M4all application has been filed to the EMA
- NDA was based on P-III (PURPOSE 1 & PURPOSE 2) trials assessing lenacapavir (SC; twice yearly) vs Truvada (F/TDF; PO, QD), where PURPOSE 1 focussed on cisgender women, while PURPOSE 2 assessed gender-diverse individuals incl. geographically diverse range of cisgender men
- PURPOSE 1 showed 0 infections & 100% risk reduction & superiority in women while PURPOSE 2 showed 99.9% non-infection rate (2 pts acquired HIV) & 96% risk reduction & superiority in contrast to bHIV
Ref: Businesswire | Image: Gilead
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