Alnylam Pharma : FDA Accepts SNDA For Patisiran For Treatment Of Cardiomyopathy Of ATTR Amyloidosis

(RTTNews) - Alnylam Pharmaceuticals Inc. (ALNY) said Tuesday that the U.S. Food and Drug Administration has accepted for filing the company's supplemental New Drug Application for ONPATTRO or patisiran, an investigational RNAi therapeutic in development for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis.

The FDA has set an action date of October 8, 2023 under the Prescription Drug User Fee Act (PDUFA).

Patisiran is the established name for ONPATTRO, which is currently approved by the U.S. FDA for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.

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