​Amgen announced new detailed data from the Phase 3 YUKAWA-2 study evaluating Repatha (evolocumab), a novel investigational cholesterol-lowering medication, in Japanese patients with high cardiovascular risk and high cholesterol. Data from the study showed subcutaneous Repatha 140 mg every two weeks or 420 mg monthly, compared to placebo, in combination with different daily doses of atorvastatin, reduced low-density lipoprotein cholesterol (LDL-C) by 67 to 76 percent from baseline at week 12 and at the mean of weeks 10 and 12. The data were presented at the American College of Cardiology’s 64th Annual Scientific Session (ACC.15).

 

In the YUKAWA-2 study, the most common 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). 

 

“The positive results from this study in Japan add to the consistent findings we have seen with Repatha across patient populations in our comprehensive 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 Repatha may help lower their LDL cholesterol levels when statins are not sufficient. We look forward to working with regulatory authorities in Japan to bring this new investigational medication to patients.”

 

Repatha 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, or “bad” cholesterol, from the blood.1 In Japan, LDL-C levels are not adequately controlled for many high-risk patients taking statins, nearly half of whom have not reached their LDL-C goal.

 

“Statins are a cornerstone of treatment for people with high cholesterol who are unable to lower their LDL cholesterol to appropriate levels despite efforts to improve diet and exercise,” said Arihiro Kiyosue, Department of Cardiovascular Medicine, Graduate School of Medicine, University of Tokyo, Japan, and Tokyo-Eki Center-building Clinic, Tokyo, Japan, and investigator for the YUKAWA-2 study. “We are encouraged by the results from the Phase 3 YUKAWA-2 study, which show that adding evolocumab to stable statin therapy in high-risk patients further reduced LDL cholesterol.” 

 

High cholesterol is the most common form of dyslipidemia, which is an abnormality of cholesterol and/or fats in the blood. There are approximately 300 million cases of dyslipidemia in the U.S., Japan and Western Europe.

 

Source: Amgen