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Ionis Subsidiary Akcea Encouraged By Safety Data In FCS

 
• By Joseph Haas

Phase III data showing statistically significant reduction of triglycerides will bolster the pivotal data expected early next year. Akcea is not concerned by the study’s 20% dropout rate because there were no discontinuations in a subset of patients with FCS.

Awaiting data from its pivotal APPROACH trial during the first quarter of 2017, Akcea Therapeutics was encouraged by safety and efficacy data unveiled Dec. 19 for lead candidate volanesorsen from a separate Phase III study in patients with severe hypertriglyceridemia, including a subset of patients with familial chylomicronemia syndrome (FCS).

Akcea, a subsidiary of antisense-focused Ionis Pharmaceuticals Inc., hopes to file volanesorsen for FCS in 2017 and plans a...

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