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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