TOKYO (June 18, 2019) –, 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 <70 mg / dL according to Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2017. There are a certain number of hypercholesterolemia patients for whom statin therapy is not suitable due to side effects such as muscle pain. This approval has great significance for such high-risk patients.”

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. 1.2

1 Horton, J. D., Cohen, J. C., & Hobbs, H. H. (2007). Molecular biology of PCSK9: its role in LDL metabolism. Trends in biochemical sciences, 32(2), 71-77.
2 Brown, M. S., & Goldstein, J. L. (2006). Lowering LDL: Not only how low, but how long? Science, 311(5768), 1721-1723.

 

Repatha® was approved for the treatment of familial hypercholesterolemia or hypercholesterolemia, only in patients with a high risk of cardiovascular events and who do not adequately respond to statins, in Japan in January 2016 and was launched in April of that year. In July 2018, the results of the 27,564-patient (including 429 Japanese patients) Repatha® cardiovascular outcomes study (FOURIER) were added to the “clinical results” section of the Repatha® prescribing information due to  the efficacy of Repatha® in the primary endpoint of cardiovascular event reduction in the treatment of hypercholesterolemia, supporting the indication for which 
Repatha® is approved.

Additionally, in drug price revisions in April 2018, the premium for verification of  true clinical usefulness (5% premium) was applied to Repatha® on the basis of results of the FOURIER.

Amgen Astellas and Astellas are hopeful that this new approval for supplemental indications will lead to a new treatment alternatives for patients who are not suitable for statin therapy and will contribute further to meeting the needs of these patients in the treatment of hypercholesterolemia.