Alnylam announces extension of review period for new drug vutrisiran to treat ATTR amyloidosis
Alnylam announces 3-month extension of review period for new drug application for vutrisiran to treat ATTR amyloidosis.
Alnylam Pharmaceuticals, Inc., a RNAi therapeutics company, announced that the FDA has extended the review timeline of the New Drug Application (NDA) for vutrisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated (ATTR) amyloidosis, to allow for the review of newly added information related to the new secondary packaging and labelling facility.
Alnylam recently learned that the original third-party secondary packaging and labelling facility the Company planned to use for the vutrisiran launch was recently inspected and the inspection requires classification for the FDA to take action on the vutrisiran NDA. The inspection observations were not directly related to vutrisiran. In order to minimize delays to approval, Alnylam has identified a new facility to pack and label vutrisiran and submitted an amendment to the NDA for review by the FDA. The updated Prescription Drug User Fee Act (PDUFA) goal date to allow for this review is July 14, 2022. No additional clinical data have been requested by the FDA.
Navigating hATTR amyloidosis
The e-learning module below explains the pathophysiology and path to diagnosis of hereditary ATTR amyloidosis, with a focus on polyneuropathy symptoms. Throughout the module, Dr Isabel Conceição, a consultant in neurology and clinical neurophysiology, provides her expert opinion.
Navigating hATTR amyloidosis
The e-learning module below explains the pathophysiology and path to diagnosis of hereditary ATTR amyloidosis, with a focus on cardiac symptoms. Throughout the module, Dr Pablo García-Pavia, a consultant cardiologist, provides his expert opinion.
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