Shots:
- FDA has approved Yeztugo for PrEP in individuals (≥35kgs) at risk of HIV. MAA & EU-M4all filing are under EMA review, with ongoing reviews in Australia, Brazil, Canada, & South Africa; further filings are planned in Argentina, Mexico, & Peru
- Approval was based on P-III (PURPOSE 1 & 2) trials assessing Yeztugo (SC; twice yearly) vs Truvada (F/TDF; PO, QD), where PURPOSE 1 focused on cisgender women, while PURPOSE 2 assessed gender-diverse people 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: Businesswire| Image: Gilead| Press Release
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