Amgen has filed its closely watched PCSK9 inhibitor Repatha (evolocumab) in Japan for the treatment of high cholesterol.
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 treatment goals, the firm noted, highlighting the need for new treatment approaches.
Repatha is being developed in Japan by Amgen Astellas BioPharma KK, a joint venture between Amgen and Astellas Pharma.
Amgen has also filed the drug in the US, where it is expecting a decision by Aug 27, and in the European Union, via the centralised procedure.