Alnylam Pharmaceuticals Reports the US FDA’s sNDA Acceptance of Amvuttra (Vutrisiran) to Treat ATTR Amyloidosis with Cardiomyopathy
Shots:
- The US FDA has accepted the sNDA of Amvuttra (RNAi therapeutic) for treating ATTR amyloidosis with cardiomyopathy (ATTR-CM), with the decision anticipated on March 23, 2025 (the company used Priority Review Voucher)
- The application was based on global P-III (HELIOS-B) study assessing the safety & efficacy of Amvuttra vs PBO for the treatment of patients with ATTR-CM
- Study depicted improved outcomes in death, cardiovascular events, functional capacity, and quality of life in ATTR-CM patients along with a favorable safety & tolerability. Data was highlighted at the ESC Congress 2024 and published in The New England Journal of Medicine
Ref: Alnylam | Image: Alnylam
Related News:- Alnylam Reports the Submission of Regulatory Application of Amvuttra (Vutrisiran) to the EMA Treating ATTR Amyloidosis with Cardiomyopathy
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
