Posted by Michael Wonder on 12 Jul 2018
Akcea and Ionis announce approval of Tegsedi (inotersen) in the European Union
11 July 2018 - Akcea Therapeutics, an affiliate of Ionis Pharmaceuticals, and Ionis Pharmaceuticals, announced today that Tegsedi (inotersen) has received marketing authorisation approval from the European Commission for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis.
This follows the positive opinion recommending approval provided by the CHMP of EMA.
The European Commission’s approval of Tegsedi was based on results from the Phase 3 NEURO-TTR study in patients with hereditary transthyretin amyloidosis with symptoms of polyneuropathy. Results from that study demonstrated that patients treated with Tegsedi experienced significant benefit compared to patients treated with placebo across both co-primary endpoints: the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy and modified Neuropathy Impairment Score +7, a measure of neuropathic disease progression.
