Posted by Michael Wonder on 26 Jan 2018
Alnylam Announces EMA acceptance of marketing authorisation application for patisiran for the treatment of hereditary ATTR amyloidosis
25 January 2018 - EMA will evaluate the application under accelerated assessment.
Alnylam Pharmaceuticals the leading RNAi therapeutics company, announced today that the EMA has accepted the Marketing Authorisation Application (MAA) and initiated its review for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of hereditary ATTR (hATTR) amyloidosis.
The filing of the MAA was previously announced on 18 December 2017, and patisiran was previously granted accelerated assessment by the EMA, potentially reducing the Agency’s evaluation time from 210 to 150 days.
