Posted by Michael Wonder on 02 Jun 2018
Akcea and Ionis receive positive EU CHMP opinion for Tegsedi
1 June 2018 - Akcea Therapeutics and Ionis Pharmaceuticals announced today that the CHMP of the EMA has adopted a positive opinion recommending approval of Tegsedi (inotersen) for the treatment of Stage 1 or Stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis.
The positive opinion will now be referred to the European Commission, which grants marketing authorization for medicines in the European Union, as well as to European Economic Area members Iceland, Liechtenstein and Norway. Tegsedi is also under regulatory review for marketing approval in the United States and Canada.
The positive CHMP opinion for the Tegedi Marketing authorisation application is based on results from the Phase 3 NEURO-TTR study and the Open Label Extension study in patients with hATTR amyloidosis with symptoms of polyneuropathy.
