Amgen Seeks Japanese OK for Anti-Cholesterol Drug Evolocumab
Amgen has submitted an application seeking marketing approval of Repatha (evolocumab) for the treatment of high cholester to the Ministry of Health, Labor and Welfare in Japan. Repatha is being developed in Japan by Amgen Astellas BioPharma K.K., a joint venture between Amgen and Astellas Pharma Inc., a pharmaceutical company headquartered in Tokyo.
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.
In the US,, Amgen submitted a biologics license application for Repatha for the treatment of high cholesterol to the US Food and Drug Administration (FDA) in August 2014. The FDA’s Prescription Drug User Fee Act target action date is August 27, 2015. In the European Union, Amgen submitted a marketing authorization application to the European Medicines Agency via the centralized procedure for Repatha for the treatment of high cholesterol in September 2014.
Repatha (evolocumab) is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that targets LDL receptors for degradation and thereby reduces the liver’s ability to remove LDL-C, or “bad” cholesterol, from the blood. Repatha, being developed by Amgen scientists, is designed to bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface. In the absence of PCSK9, there are more LDL receptors on the surface of the liver to remove LDL-C from the bloodource.