Alnylam Reports the Submission of Regulatory Application of Amvuttra (Vutrisiran) to the EMA Treating ATTR Amyloidosis with Cardiomyopathy
Shots:
- Alnylam has submitted Type II Variation application to the EMA, seeking approval for Amvuttra to treat ATTR amyloidosis with cardiomyopathy (ATTR-CM). sNDA for the same has also been submitted to the US FDA with further filings expected worldwide
- Submission was based on the P-III (HELIOS-B) trial assessing the safety & efficacy of Amvuttra vs PBO for treating ATTR-CM
- Study achieved all ten 1 & 2EPs with statistical significance, showing the drug’s efficacy on mortality, cardiovascular events, functional capacity, quality of life & heart failure severity in patients with ATTR-CM, with a safety profile similar to prior findings. Full results were published in The New England Journal of Medicine
Ref: Alnylam Pharmaceuticals | Image: Alnylam Pharmaceuticals
Related News: Alnylam’s Amvuttra (vutrisiran) Receives EC’s Approval for the Treatment of Hereditary Transthyretin-mediated Amyloidosis
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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.
