Amgen Astellas BioPharma K.K. and Astellas Pharma Inc. announced the launch of Repatha SC Injection 420 mg Auto Mini Doser (AMD), an additional dosage formulation to Repatha SC Injection 140 mg Syringe and Pen. Repatha is the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in Japan for the treatment of patients with familial hypercholesterolemia or hypercholesterolemia who have high risk of cardiovascular events and do not adequately respond to HMG-CoA reductase inhibitors (statins). The new Repatha SC Injection 420 mg AMD is a new dosage form consisting of a compact, palm-sized device with prefilled cartridge and a dedicated injection system. While the conventional syringes and pens required three subcutaneous injections of 140 mg to administer 420 mg, Repatha SC Injection 420 AMD delivers a single dose in 9 minutes with a hands-free delivery system, allowing the patient to walk, stretch their arms, bend at the waist, or do other moderate everyday activities. Another characteristic of the product design is the needle which stays hidden during administration. Repatha (evolocumab) is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha 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. Repatha is approved in more than 50 countries, including the U.S., Japan, Canada and in all 28 countries that are members of the EU. Applications in other countries are pending. Indications: Familial hypercholesterolemia, Hypercholesterolemia; Only when patients who have high risk in cardiovascular events and do not adequately; respond to HMG-CoA reductase inhibitors. Precautions Related to Indications: Prior to Repatha therapy, patients should undergo adequate medical examination and tests to confirm a diagnosis of familial hypercholesterolemia or hypercholesterolemia. In patients with non-familial hypercholesterolemia, the use of Repatha should be considered for patients with high risk of cardiovascular events based on confirmed risk factors e.g. comorbid conditions including coronary artery disease, non-cardiogenic cerebral infarction, peripheral arterial disease, diabetes mellitus and chronic renal disease or medical history. Dosage and Administration: Heterozygous Familial Hypercholesterolemia and Hypercholesterolemia [Repatha SC Injection 140 mg Syringe/Pen] in general, for adults, evolocumab (genetically recombination) of 140 mg is administrated every 2 weeks or evolocumab of 420 mg is administrated every 4 weeks subcutaneously. [Repatha SC Injection 420 mg AMD] in general, for adults, evolocumab (genetically recombination) of 420 mg is administrated every 4 weeks subcutaneously. Homozygous Familial Hypercholesterolemia: In general, for adults, 420 mg of evolocumab (genetical recombination) is administrated subcutaneously every 4 weeks. In case of insufficient response, 420 mg of evolocumab can be administered subcutaneously every 2 weeks. If evolocumab is administered as adjunctive therapy for patients with LDL apheresis, as starting dose, 420 mg of evolocumab can be administered subcutaneously every 2 weeks. Repatha should be administered in combination with HMG-CoA reductase inhibitor-based lipid lowering therapy.