Posted by Michael Wonder on 13 Nov 2017
EMA grants Alnylam accelerated assessment of patisiran for patients with hereditary ATTR amyloidosis
13 November 2017 - Company on track to submit marketing authorisation application and new drug application at year end 2017.
Alnylam Pharmaceuticals announced today the CHMP of the EMA has granted an accelerated assessment for patisiran, an investigational RNAi therapeutic targeting transthyretin for the treatment of hereditary ATTR amyloidosis. The EMA awards an accelerated assessment to medicines deemed to be of major public health interest and therapeutic innovation, and the award is designed to bring new treatments to patients more quickly. Alnylam intends to file a marketing authorisation application in the European Union at year-end 2017. Accelerated assessment potentially provides a reduced review timeline from 210 to 150 days once the application is filed and validated.
