Alnylam Pharma Decides Not To Pursue Expanded Indication For Patisiran In The U.S.

(RTTNews) - Alnylam Pharmaceuticals, Inc. (ALNY) announced the FDA has issued a Complete Response Letter in response to the company's supplemental New Drug Application for patisiran for the treatment of the cardiomyopathy of transthyretin-mediated amyloidosis. The CRL indicated that the clinical meaningfulness of patisiran's treatment effects for the cardiomyopathy of ATTR amyloidosis had not been established. As a result, Alnylam Pharma will no longer pursue an expanded indication for patisiran in the U.S.

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

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