Amgen Astellas Biopharma and Astellas Introduce new treatment option for the high cholesterol patients

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FIrst PCSK9 Inhibitor in Japan,Providing A new TREATMENT option for certain patients who have high risk in cardiovascular events and do not adequately respond to statins.

World pharma today/Drug research/- Amgen Astellas BioPharma K.K. (Headquarters, Tokyo; General Manager and Representative Director: Eiichi Takahashi, “Amgen Astellas”) and Astellas Pharma Inc. (Headquarters, Tokyo; President and CEO: Yoshihiko Hatanaka, “Astellas”)  announced that proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor Repatha® SC Injection (generic name: Evolocumab (Genetically Recombination) Injection) 140 mg Syringe has become available in the Japanese market today.

Repatha® is indicated for the treatment of patients with familial hypercholesterolemia (FH) or hypercholesterolemia who have high risk of cardiovascular events and do not adequately respond to HMG-CoA reductase inhibitors (statins).

Repatha® is a human monoclonal antibody that inhibits PCSK9.1Repatha® binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha® increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.2

Yukiya Suzuki, the Head of Sales and Marketing of Amgen Astellas said, “Amgen Astellas is a Tokyo-based joint venture between Amgen, a biotechnology company with a history of more than 35 years of providing innovative medicines worldwide, and Astellas Pharma Inc., a company with a deep understanding and expertise in serving the medical needs of Japanese patients and physicians. Amgen Astellas began operations in 2013, and today we are pleased to begin providing Repatha®, the first product of Amgen Astellas and Japan’s first PCSK9 inhibitor. We are committed to serving the medical needs of the country and are excited about the potential of Repatha® to help improve the treatment of patients with high cholesterol who have high risk in cardiovascular events and do not adequately respond to statins.”

Yukihiko Sato, Senior Vice President, Sales & Marketing Japan of Astellas said, ”We expect Repatha® as a new therapeutic option will contribute further to the patients with cardiovascular disease.”

Amgen Astellas and Astellas will co-promote Repatha®.

Product outline of “Repatha® SC Injection 140mg Syringe” is as follows.