- The FDA has extended the review timeline for Alnylam Pharmaceuticals Inc's (NASDAQ: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.
