Market Overview

Amgen's Repatha Approved in Japan as First PCSK9 Inhibitor for Treatment of High Cholesterol

Share:

Amgen (NASDAQ: AMGN) today announced that the Japanese Ministry of Health, Labour and Welfare has approved the cholesterol-lowering medication Repatha® (evolocumab) Injection, the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in Japan. Repatha is a human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood.1 Repatha was developed in Japan by Amgen Astellas BioPharma K.K. (AABP), a joint venture between Amgen and Astellas Pharma Inc., a pharmaceutical company headquartered in Tokyo.

In Japan, Repatha is indicated for the treatment of patients with familial hypercholesterolemia (FH) or hypercholesterolemia who have high risk of cardiovascular events and do not adequately respond to HMG-CoA reductase inhibitors (statins).

"Today's approval of Repatha, the first PCSK9 inhibitor approved in Japan, is an important milestone for patients and physicians who need additional treatment options to lower LDL cholesterol," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "High LDL cholesterol is a modifiable risk factor for cardiovascular disease and

See full press release

Posted-In: News FDA Press Releases

 

Related Articles (AMGN)

View Comments and Join the Discussion!