FDA reviewers question Akcea candidate's safety

FDA reviewers said volanesorsen from Akcea Therapeutics Inc. (NASDAQ:AKCA) will "almost certainly" require a REMS if approved, although even that step "may not be sufficient" to ensure the candidate's safe use due to risks of thrombocytopenia and serious bleeding. The remarks came in briefing documents issued ahead of Thursday's planned advisory committee meeting to review an NDA for volanesorsen to treat familial chylomicronemia syndrome, a rare lipid disorder that results from lipoprotein lipase deficiency.

Akcea lost $2.87 (13%) to $18.80 on Tuesday. The company is developing the antisense inhibitor of apolipoprotein C-III (APOCIII; APOC3) with Ionis Pharmaceuticals Inc. (NASDAQ:IONS), which slid $3.81 to $40.53 on Tuesday. ...