Delay for Akcea's volanesorsen

Akcea Therapeutics Inc. (NASDAQ:AKCA) said it received a complete response letter for Waylivra volanesorsen to treat familial chylomicronemia syndrome (FCS), going against an FDA panel vote in May that backed approval of the compound.

The company is developing Waylivra with Ionis Pharmaceuticals Inc. (NASDAQ:IONS). The antisense inhibitor of apolipoprotein C-III (APOCIII; APOC3) is also under review in the EU and Canada, and has Orphan Drug designation in the U.S. and EU. ...