Shots:
- The EMA has accepted MAA & EU-M4all as well as granted priority review to lenacapavir (HIV-1 capsid inhibitor) for PrEP in humans at risk of HIV; MAA will be applicable in 30 EEA states (incl. Norway, Iceland & Liechtenstein)
- MAA 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
Related News:- Gilead Reports US FDA’s NDA Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk
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