Amgen Astellas BioPharma K.K. (Headquarters, Tokyo; President and Representative Director: Steve Sugino, ‘Amgen Astellas’) and Astellas Pharma Inc. (Headquarters, Tokyo; President and CEO: Kenji Yasukawa, Ph.D., ‘Astellas’) today announced that Amgen Astellas has received approval in Japan for a supplemental indication for the hypercholesterolemia drug Repatha® SC Injection (evolocumab (Genetical Recombination), ‘Repatha®‘). The supplemental indication is for treating hypercholesterolemia patients who are not suitable for HMG-CoA reductase inhibitor (‘statin’) therapy.
As defined in Precautions Related to Dosage and Administration section of the previous prescribing information, Repatha® was originally approved for use in combination with statins only. The approval for the supplemental indication will make it possible for Repatha® to be used alone in familial hypercholesterolemia or hypercholesterolemia patients for whom statin therapy is not suitable, due to a history of side effects or contraindication.
Shizuya Yamashita, M.D., Ph.D., Vice Chairman/Director of Rinku General Medical Center says, ‘The management of low-density lipoprotein (LDL) cholesterol (LDL-C) is key to the prevention of coronary artery disease such as angina pectoris and myocardial infarction. In regards to secondary prevention, patients with acute coronary syndrome, high-risk type 2 diabetes, or familial hypercholesterolemia, should target LDL-C
Jointly developed by Amgen Astellas and Astellas in Japan, Repatha® is a human IgG2 monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the ability of hepatic LDL receptors to remove LDL-C, or ‘bad’ cholesterol, from the blood.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.