Data from Pharmawand - Curated by EPG Health - Date added 13 July 2018

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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