Alnylam Pharma Submits Type II Variation To European Medicines Agency For Vutrisiran

(RTTNews) - Alnylam Pharmaceuticals (ALNY) announced the submission of a Type II Variation to the European Medicines Agency for vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy. Vutrisiran is the generic name for AMVUTTRA, which is currently approved in the European Union for the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.

The company said the regulatory application is based on positive results from the HELIOS-B Phase 3, randomized, double-blind, placebo-controlled multicenter global study. A sNDA for vutrisiran has been submitted to the FDA for the treatment of ATTR-CM.

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