Posted by Michael Wonder on 05 Oct 2018
Akcea and Ionis receive FDA approval of Tegsedi (inotersen) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
5 October 2018 - Tegsedi provides powerful knockdown of TTR protein, delivering significant and sustained benefits in neuropathy and quality of life.
Akcea Therapeutics and Ionis Pharmaceuticals announced today that the U.S. FDA has approved Tegsedi (inotersen) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Tegsedi is now approved in the U.S., European Union and Canada.
The FDA’s approval of Tegsedi was based on results from the Phase 3 NEURO-TTR study in patients with hATTR 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.
