Posted by Michael Wonder on 04 Apr 2022
Alnylam announces three month extension of review period for new drug application for vutrisiran
4 April 2022 - New PDUFA goal date scheduled for 14 July 2022.
Alnylam Pharmaceuticals announced that the U.S. 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 labelling facility.
