Evolocumab是公司和日本安斯泰来制药共同开发的一种实验性全人源单抗，属于PCSK9抑制剂，能改善肺部降低低密度脂蛋白胆固醇（LDL-C） 水平的能力。安进于周四同时向美国食品药品监督管理局提交Evolocumab单抗的生物制品许可申请（BLA）。
安进公司此次进行的是多中心、双盲、随机、安慰剂对照临床III期试验，共有404位高心血管风险和高胆固醇患者参与。此次临床研究达到预期目标，即患者在接受治疗12周之后，体内LDL-C下降至70mg/dl以下。
Amgen (Nasdaq: AMGN) announced that the Phase 3 YUKAWA-2 (StudY of LDL-Cholesterol Reduction Using a Monoclonal PCSK9 Antibody in Japanese Patients With Advanced Cardiovascular Risk) study evaluating evolocumab in combination with statin therapy in Japanese patients with high cardiovascular risk and high cholesterol met its co-primary endpoints: the percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12. The percent reduction in LDL-C, or "bad" cholesterol, was clinically meaningful, statistically significant, and consistent with the results observed for the same doses in the Phase 2 YUKAWA trial for evolocumab compared to placebo.1
Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood.2
The YUKAWA-2 trial evaluated safety, tolerability and efficacy of evolocumab compared to placebo in combination with statin therapy in 404 Japanese patients with high cardiovascular risk and high cholesterol. Patients were randomized to one of eight treatment groups to compare subcutaneous evolocumab (140 mg every two weeks or 420 mg monthly) with subcutaneous placebo (every two weeks or monthly) when added to different daily doses of atorvastatin.
Safety was balanced across treatment groups. The adverse events (AEs) that occurred in > 2 percent of the evolocumab combined group were nasopharyngitis, gastroenteritis and pharyngitis.
"We are encouraged by the evolocumab data from the YUKAWA-2 study in the Japanese patient population and the remarkable consistency we have seen across our clinical program," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Statins are an important therapy for patients with high cholesterol and adding evolocumab may help lower their LDL cholesterol levels when statins are not sufficient."
Details of the Phase 3 YUKAWA-2 study results will be submitted to a future medical conference and for publication.
High cholesterol is the most common form of dyslipidemia, which is an abnormality of cholesterol and/or fats in the blood.3,4 There are approximately 300 million cases of dyslipidemia in the U.S., Japan and Western Europe.5 According to the Centers for Disease Control and Prevention, more than 71 million American adults have high LDL-C,6 and elevated LDL-C is recognized as a major risk factor for cardiovascular disease.7,8 In Japan, LDL-C levels are not adequately controlled for many high risk patients taking statins, nearly half of which have not reached their LDL-C goal.9-12.
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