Shots:
- The CHMP has recommended approval of the MAA & EU-M4all application of lenacapavir as PrEP for individuals at risk of HIV across all 30 EEA states. It will be marketed in the EU as Yeytuo, if approved by the EC by late 2025
- Opinion 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 in 2134 women, while PURPOSE 2 showed 99.9% non-infection rate in 2179 pts (2 acquired HIV), demonstrating superiority in contrast to bHIV in both trials; data was published in The NEJM
Ref: Gilead| Image: Gilead| Press Release
Related News:- Gilead Reports the US FDA’s Approval of Yeztugo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk
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