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Alnylam’s Amvuttra (vutrisiran) Receives the US FDA’s Approval for Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis

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Alnylam’s Amvuttra (vutrisiran) Receives the US FDA’s Approval for Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis

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  • The approval was based on the 9mos. results from the P-III (HELIOS-A) study evaluating Amvuttra vs patisiran in a ratio (3:1) in 164 patients with hATTR amyloidosis with polyneuropathy. The product is expected to be available in early July
  • The trial met the 1EPs & 2EPs i.e., improvement in mNIS+7 from baseline @9mos. (2.2point vs 14.8 point), 50% experienced an improvement in neuropathy impairment relative to baseline, Norfolk QoL-DN score & 10-MWT
  • Improvements in exploratory EPs, and efficacy results were consistent with 9mos. data with no drug-related discontinuations or deaths. The company provides Alnylam Assist, a patient support program that helps patients access Amvuttra, verifies insurance benefits & provides financial assistance to qualified patients

Ref: Bussinesswire | Image: Alnylam

 

 

Click here to­ read the full press release 

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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