Clinical Data
Data from the global Phase 3 ODYSSEY trials showed consistent, robust reductions in LDL cholesterol for Praluent compared to placebo, when added to current standard-of-care, which included maximally-tolerated statins. The Phase 3 ODYSSEY JAPAN trial evaluated the safety and efficacy of Praluent 75 mg starting dose every two weeks, in comparison with placebo in 216 Japanese patients with primary hypercholesterolemia and LDL cholesterol of at least 100 milligrams/deciliter (mg/dL) (at least 2.59 millimoles per liter [mmol/L]). All study patients were on ongoing statin treatment with or without other lipid-lowering therapies. Average baseline LDL cholesterol levels in the randomized population were similar between the Praluent (141 mg/dL / 3.6 mmol/L) and placebo groups (142 mg/dL / 3.7 mmol/L). Patients in the Praluent group who did not achieve their pre-specified LDL cholesterol goals with Praluent 75 mg at week 8 (2 out of 140 patients who continued treatment beyond week 12) were increased to Praluent 150 mg every two weeks at week 12.In the ODYSSEY JAPAN trial, Praluent reduced LDL cholesterol by 63 percent at week 24 on top of stable background statin therapy, compared to a 2 percent increase in the placebo group (p<0.0001, ITT analysis). Patients treated with Praluent maintained their LDL cholesterol reductions for the duration of the trial. By week 52 patients in the Praluent group achieved an average LDL cholesterol of 53.4 mg/dL (1.38 mmol/L) compared to an average LDL cholesterol of 135.6 mg/dL (3.51 mmol/L) in the placebo group (ITT population).In the trial, Praluent was generally well-tolerated with an acceptable safety profile. Frequently reported adverse events included nasopharyngitis (46 percent Praluent versus 36 percent placebo); back pain (13 percent Praluent versus 6 percent placebo); and injection site reaction (13 percent Praluent versus 4 percent placebo).