Shots:
- The CHMP has recommended vutrisiran to treat ATTR-CM adults based on global P-III (HELIOS-B) study assessing it vs PBO in ATTR-CM pts; EC’s decision expected in Jun 2025. MAA under PMDA review, with global applications planned in 2025 & beyond
- Study met all ten 1 & 2EPs across both overall & monotx. arms, showing improved outcomes of mortality, CV events & functional capacity with 6min. walk test
- Trial also showed benefits across health status, QoL (Kansas City Cardiomyopathy Questionnaire), plus heart failure symptoms & severity (NYHA class); findings were consistent across all subgroups incl. pts on a concomitant TTR stabilizer. Data was published in The NEJM
Ref: BusinessWire | Image: Alnylam
Related News:- Alnylam Pharmaceuticals Reports the US FDA’s Approval of Amvuttra (Vutrisiran) to Treat ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)
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