Alnylam announces FDA acceptance of patisiran sNDA

Alnylam announced that the FDA has accepted for filing the company’s supplemental new drug application, or sNDA, for patisiran, an investigational RNAi therapeutic in development for the treatment of the cardiomyopathy of transthyretin-mediated, or ATTR, amyloidosis. The FDA has set an action date of October 8 under the Prescription Drug User Fee Act, or PDUFA. In their file acceptance letter, the FDA stated that they have not identified any review issues. The agency also noted that they are planning to hold an advisory committee meeting to discuss the application. Patisiran is the established name for Onpattro, which is currently approved by the FDA for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.