BioCentury
ARTICLE | Company News

Akcea's volanesorsen under review for FCS

November 15, 2017 6:39 PM UTC

Akcea Therapeutics Inc. (NASDAQ:AKCA) said each of its U.S., EU and Canadian regulatory applications for volanesorsen (IONIS-APOCIIIRx) to treat familial chylomicronemia syndrome (FCS) has been accepted for review. FDA assigned the candidate’s NDA a PDUFA date of Aug. 30, 2018.

The apolipoprotein C-III (APOCIII; APOC3) antisense inhibitor has Orphan Drug designation in the U.S. and EU. It also has promising innovative medicine (PIM) designation in the U.K...