Akcea submits MAA for volanesorsen to treat familial chylomicronemia syndrome

Akcea Therapeutics Inc. (NASDAQ:AKCA) submitted an MAA to EMA for volanesorsen (IONIS-APOCIIIRx, ISIS 304801) to treat familial chylomicronemia syndrome (FCS).

The MAA is based on data from the Phase III APPROACH trial in 66 patients with FCS which showed that once-weekly 300 mg subcutaneous volanesorsen for 52 weeks met the primary endpoint of reducing mean triglyceride levels from baseline to 3 months vs. placebo (77% vs. an increase of 18%, p<0.0001) (see BioCentury, March 13)...