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Inotersen for hATTR Amyloidosis Received Positive Opinion by CHMP in Europe

Inotersen for hATTR Amyloidosis Received Positive Opinion by CHMP in Europe

The Akcea Team announced that the Committee for Medicinal Products for Human Use (CHMP) of the Eurpoean Medicines Agency (EMA) adopted a postive opinion recommending approval of TEGSEDI (inotersen) for the treatment of state 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).

From here, the positive opinion will be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union, as well as to European Economic Area members Iceland, Liechtenstein and Norway.

Click here for the press release.