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Amgen's Repatha (Evolocumab) Approved As First PCSK9 Inhibitor In Japan For The Treatment Of High Cholesterol

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Results from Phase 3 studies showed that adding Repatha to background lipid-lowering therapy that included statins resulted in intensive reductions in LDL-C. YUKAWA-2, a pivotal Phase 3 study in Japanese patients with high cardiovascular risk and high cholesterol, demonstrated that subcutaneous Repatha 140 mg every two weeks or 420 mg every four weeks, compared to placebo, in combination with daily doses of atorvastatin, reduced LDL-C by 67 to 76 percent from baseline at week 12 and at the mean of weeks 10 and 12.2 The adverse events that occurred in greater than 2 percent of the Repatha group were nasopharyngitis (16.8 percent Repatha; 17.8 percent placebo), gastroenteritis (3.0 percent Repatha; 1.0 percent placebo) and pharyngitis (2.5 percent Repatha; 2.5 percent placebo).3 Results from TAUSSIG, a global, open-label, single-arm study in patients with homozygous FH, including patients in Japan, showed Repatha reduced LDL-C by approximately 23 percent.4 The adverse events that occurred in greater than 5 percent of patients were nasopharyngitis (9.0 percent) and influenza (7.0 percent).4
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Jan 21, 2016
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Related Keywords Repatha, Evolocumab, Japan, Approval, Pcsk9 Inhibitor, High Cholesterol, Ldl-c, Proprotein Convertase Subtilisin/kexin Type 9, Human Monoclonal Antibody