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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April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.