European Commission approves Tegsedi to treat stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis.- Akcea Therapeutics + Ionis Pharma.
Akcea Therapeutics, Inc , an affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. announced that Tegsedi (inotersen) has received marketing authorization approval from the European Commission (EC) for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR). This follows the positive opinion recommending approval provided by the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency (EMA).
Comment: In the U.S., Tegsedi has a PDUFA date of 6 October 2018.
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