Alnylam Pharmaceuticals Reports the US FDA’s Approval of Amvuttra (Vutrisiran) to Treat ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)
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- The US FDA has approved sNDA of Amvuttra to treat ATTR-CM adults based on global P-III (HELIOS-B) study assessing it vs PBO in ATTR-CM pts for 36wks, followed by a 6wk. OLE study; MAA under EMA, ANVISA & PMDA review, with global applications planned in 2025
- Study showed benefits across all ten 1 & 2EPs, showing 28% decline in all-cause mortality & recurrent CV events over ~36mos. in all pts & 33% decline in monotx. arm. Mortality reduced by 36% & 35% over 42mos. in overall & monotx. populations, respectively
- Pts observed preserved function, QoL, & early biomarker improvements (NT-proBNP & troponin I). Data was presented at the ESC Congress 2024 & published in The NEJM
Ref: Businesswire | Image: Alnylam
Related News:- Alnylam Pharmaceuticals Reports the US FDA’s sNDA Acceptance of Amvuttra (Vutrisiran) to Treat ATTR Amyloidosis with Cardiomyopathy
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
