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Alnylam’s Amvuttra (vutrisiran) Receives EC’s Approval for the Treatment of Hereditary Transthyretin-mediated Amyloidosis

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Alnylam’s Amvuttra (vutrisiran) Receives EC’s Approval for the Treatment of Hereditary Transthyretin-mediated Amyloidosis

Shots:

  • The EC has granted marketing authorization for Amvuttra to treat hATTR amyloidosis in adult patients with stage 1 or 2 polyneuropathy
  • The approval was based on the 18mos. results from the P-III (HELIOS-A) study evaluating Amvuttra. The trial met its 1EPs & 2EPs at 9 & 18mos. which showed improvement in signs & symptoms of hATTR amyloidosis with ≥50% of patients experiencing halting or reversal of polyneuropathy manifestations along with an encouraging safety & tolerability profile, improvement in mean change from baseline in mNIS+7 @18mos. over PBO from the P-III (APOLLO) study of patisiran
  • The therapy has received ODD in the EU & US for ATTR amyloidosis & in Japan for transthyretin type familial amyloidosis with polyneuropathy

Ref: Businesswire | Image: Alnylam

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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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