Akcea Therapeutics Inc. and Ionis Pharmaceuticals Inc. announced that Waylivra received conditional marketing authorization from the European Commission as the only therapy for FCS.

An advisory committee of the EMA recommended conditionally approving a drug from Akcea Therapeutics and Ionis Pharmaceuticals that aims to treat a rare genetic disease.

The U.S. FDA declined to approve a drug from Akcea Therapeutics and Ionis Pharmaceuticals that aims to treat a genetic disease that causes fat accumulation in the blood.

Akcea Therapeutics Inc. announced that the U.S. Food and Drug Administration’s Division of Metabolism and Endocrinology Products Advisory Committee voted 12-8 to support approval of Waylivra (volanesorsen) for the treatment of people with familial chylomicronemia syndrome.