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Repatha@ Receives Approval for New 420mg Single-Dose Delivery Option in Japan

August 30, 2017

TOKYO (August 30, 2017) – Amgen Astellas BioPharma K.K. (Headquarters, Tokyo; President and Representative Director: Steve Sugino, “Amgen Astellas”) and Astellas Pharma Inc. (Headquarters, Tokyo; President and CEO: Yoshihiko Hatanaka, “Astellas”) announced that Amgen Astellas received a marketing approval of Repatha® SC Injection 420 mg Auto mini doser (AMD), an additional dosage formulation of Repatha®, a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).

 

The new Repatha SC Injection 420 mg  AMD is a single-use on-body infusor with prefilled cartridge for every-four-week subcutaneous injection. An every-two-week subcutaneous injection option is possible for homozygous familial hypercholesterolemia (FH) patients who are unable to appropriately control their LDL cholesterol level.

 

Dr. Koutaro Yokote M.D., Ph.D, Professor of Chiba University Graduate School of Medicine, Department of Diabetes, Metabolism and Endocrinology and Deputy Director of Chiba University Hospital said, “There are not a few patients who are optimally treated with the exisiting therapies such as HMG-CoA reductase inhibitors (statins) and still at high risk for cardiac event. Repatha is an important treatment option for such patients.”

 

Amgen Astellas and Astellas expect to further contribute to the treatment of patients with FH or hypercholesterolemia patients who have high risk in cardiovascular events and do not adequately respond to statins by providing this new AMD option to the already approved Repath SC Injection 140mg Syringe and Repath SC Injection 140mg pen.

 

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