Volanesorsen: Ph III APPROACH data

Top-line data from the double-blind, international Phase III APPROACH trial in 66 patients with FCS showed that once-weekly 300 mg subcutaneous volanesorsen for 52 weeks met the primary endpoint of reducing mean triglyceride levels from baseline to 3 months vs. placebo (77% vs. an increase of 18%, p<0.0001). Volanesorsen led to a mean absolute triglyceride reduction of 1,712 mg/dL. Ionis said the reductions were sustained over the trial’s 52-week treatment period. In patients with baseline triglyceride levels of ≥750 mg/dL, a significantly greater proportion of patients receiving volanesorsen achieved triglyceride levels of <500 mg/dL after 3 months vs. placebo (50% vs. 0%, p<0.003). Additionally, volanesorsen-treated patients with the highest documented frequency of pancreatitis attacks did not experience any attacks during the treatment period. Ionis also reported a reduction in abdominal pain in patients receiving volanesorsen compared to patients receiving placebo...