Posted by Michael Wonder on 18 Dec 2017
Sanofi and Alnylam submit marketing authorisation application to the European Medicines Agency for patisiran for the treatment of hereditary ATTR amyloidosis
18 December 2017 - Patisiran marketing authorisation application to be reviewed under accelerated assessment.
Sanofi Genzyme and Alnylam Pharmaceuticals announced today the submission of a marketing authorisation application to the EMA for patisiran, an investigational RNAi therapeutic targeting transthyretin for the treatment of adults with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).
Patisiran was previously granted accelerated assessment by the EMA, potentially reducing the EMA’s evaluation time from 210 to 150 days.
