Alnylam Pharma: FDA Extends Review Timeline Of NDA For Vutrisiran - Quick Facts

Alnylam Pharmaceuticals, Inc. (ALNY) said the FDA has extended the review timeline of the New Drug Application for vutrisiran, an investigational RNAi therapeutic in
development for the treatment of transthyretin-mediated amyloidosis, to allow for the review of newly added information related to the new secondary packaging and labeling facility. Alnylam said it has identified a new facility to pack and label vutrisiran and submitted an amendment to the NDA for review by the FDA. The updated PDUFA goal date to allow for this review is July 14, 2022.

Vutrisiran has been granted Orphan Drug Designation in the U.S. and the European Union for the treatment of ATTR amyloidosis, and in Japan for transthyretin type familial
amyloidosis with polyneuropathy.

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