ALNY - Alnylam says FDA extended review period for ATTR amyloidosis drug

RNAi therapeutics company, Alnylam Pharmaceuticals (NASDAQ:ALNY), announced on Monday that the U.S. Food and Drug Administration (FDA) extended its review period for vutrisiran, an experimental therapy for transthyretin-mediated (ATTR) amyloidosis. The FDA has made the decision to prolong the review in order to examine additional data on a new secondary packaging and labeling facility for vutrisiran, the company said, adding that the regulator has not requested additional data on the therapy.  The new Prescription Drug User Fee Act (PDUFA) goal date is July 14, 2022. Alnylam (ALNY) shares are trading marginally lower in the pre-market currently. “We are confident in our regulatory application and the body of data supporting the efficacy and safety of vutrisiran,” Chief Medical Officer Pushkal Garg remarked.

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Alnylam says FDA extended review period for ATTR amyloidosis drug