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Alnylam seeking European approval for genetic disease drug

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Alnylam seeking European approval for genetic disease drug

Alnylam Pharmaceuticals Inc. filed a marketing authorization application to the European Medicines Agency for patisiran to treat adults with hereditary transthyretin-mediated amyloidosis.

Hereditary transthyretin-mediated amyloidosis, or hATTR amyloidosis, is an inherited, progressively debilitating, and often fatal disease caused by mutations in the transthyretin gene.

The company's application is under accelerated assessment by the agency, with a reduced evaluation time of 150 days from 210.

Earlier, Alnylam submitted a new drug application for patisiran to the U.S. Food and Drug Administration.

The company said its partner Sanofi Genzyme, Sanofi's specialty care global business unit, is preparing regulatory filings for the drug in Japan, Brazil and other countries, with submissions to commence in the first half of 2018.