See Why Did FDA Extend Review Period For Alnylam's Vutrisiran In Amyloidosis

The FDA has extended the review timeline for Alnylam Pharmaceuticals Inc's ALNY marketing application for vutrisiran for transthyretin-mediated (ATTR) amyloidosis.
The updated Prescription Drug User Fee Act (PDUFA) goal date is July 14.
The FDA needs additional time to review newly added information related to the new secondary packaging and labeling facility for investigational RNAi therapeutic.
Alnylam's third-party secondary packaging and labeling facility was recently inspected, and the inspection requires classification for the FDA to take action on the vutrisiran application.
Related: Alnylam' Reveals Detailed 18-Month Data From Vutrisiran Trial In Inherited Disease.
The inspection observations were not directly related to vutrisiran.
To minimize delays to approval, Alnylam has identified a new facility to pack and label vutrisiran and submitted an amendment to the agency.
The FDA has requested no additional clinical data.
Vutrisiran is also under review by the European Medicines Agency, the Brazilian Health Regulatory Agency, and the Japanese Pharmaceuticals and Medical Devices Agency.
Price Action: ALNY shares are down 3.40% at $163.54 during the market session on the last check Monday.