Ionis Pharmaceuticals’s (IONS) volanesorsen is a drug designed to reduce apolipoprotein C-III production and triglycerides in patients with dyslipidemia.
Akcea Therapeutics, a wholly owned subsidiary of Ionis, is engaged in pre-commercialization activities for volanesorsen, and will take care of the drug’s commercialization once it is approved by the FDA and the European Commission. The drug is classified for use in severe and rare therapeutic areas.
APPROACH – the phase III clinical study
On March 6, 2017, Ionis Pharmaceuticals and its subsidiary Akcea Therapeutics announced positive results for APPROACH, a double-blind, randomized, placebo-controlled, phase III study for evaluating volanesorsen for the treatment of patients with FCS (familial chylomicronemia syndrome). The study evaluated the safety and efficacy of a weekly dose of 300-milligram Volanesorsen for 12 months for around 50 patients.
Presently, volanesorsen is the focus of phase III clinical studies for the treatment of patients with FPL (familial partial lipodystrophy) and has been designated as an orphan drug for the treatment of patients with FCS by the FDA and the European Medicines Agency.
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