BioCentury
ARTICLE | Clinical News

FDA panel to review volanesorsen from Akcea, Ionis

February 23, 2018 8:17 PM UTC

Akcea Therapeutics Inc. (NASDAQ:AKCA) said FDA's Division of Metabolism and Endocrinology Products will hold an advisory committee meeting to review an NDA for volanesorsen (IONIS-APOCIIIRx) to treat familial chylomicronemia syndrome (FCS), a rare lipid disorder that results from lipoprotein lipase deficiency. Akcea said the meeting is scheduled tentatively for May 10.

The antisense inhibitor of apolipoprotein C-III (APOCIII; APOC3) has a PDUFA date of Aug. 30. It is also under review in the EU and Canada, and has Orphan Drug designation in the U.S. and EU...