Posted by Michael Wonder on 04 Feb 2018
Alnylam announces FDA acceptance of new drug application and priority review status for patisiran, an investigational RNAi therapeutic for the treatment of hereditary ATTR amyloidosis
1 February 2018 - PDUFA date set for 11 August 2018.
Alnylam Pharmaceuticals announced today that the U.S. FDA has accepted for filing its new drug application for patisiran, an investigational RNAi therapeutic targeting transthyretin for the treatment of hereditary ATTR amyloidosis.
The FDA also granted the Company’s request for priority review and has set an action date of 11 August 2018, under the Prescription Drug User Fee Act. At this time, the FDA is not planning to hold an advisory committee meeting to discuss this application.
