Akcea and Ionis Receive Positive EU CHMP Opinion for TEGSEDI

Akcea Therapeutics (NASDAQ:AKCA), an affiliate of Ionis Pharmaceuticals and Ionis Pharmaceuticals (NASDAQ:IONS), announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of TEGSEDI™ (inotersen) for the treatment of Stage 1 or Stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).

As quoted in the press release:

The positive opinion will now 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. TEGSEDI is also under regulatory review for marketing approval in the United States and Canada.

“Today’s positive CHMP opinion is an important step toward making TEGSEDI available to people with this systemic, progressive and fatal hereditary disease that relentlessly deprives them of their independence and dignity,” said Paula Soteropoulos, chief executive officer at Akcea Therapeutics. “We are now anticipating approval in Europe shortly and we are ready to launch TEGSEDI to bring this new treatment to people with hATTR amyloidosis.”

Click here to read the full press release.