Amgen files for Repatha approval in Japan

Leading USA-based biotech firm Amgen (Nasdaq: AMGN) has filed for approval of Repatha (evolocumab) for the treatment of high cholesterol has been submitted for review to the Ministry of Health, Labor and Welfare in Japan.

Repatha is being developed in Japan by Amgen Astellas BioPharma KK, a joint venture between Amgen and Japanese drug major Astellas Pharma (TYO: 4503).

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 low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood. In Japan, LDL-C levels are not adequately controlled for many patients taking statins, nearly half of whom have not reached their LDL-C goal.