英文名称：IDELVION I.V. Injection（Albutrepenonacog Alfa[Genetical Recombination]）
IDELVION I.V. Injection
Albutrepenonacog Alfa（Genetical Recombination）
Albumin fusion technology realizes a high hemostatic effect at the maximum administration interval of 14 days Half-life extended hemophilia B therapeutic preparation
• Fusion of genetically engineered albumin and recombinant blood coagulation factor IX prolongs the half-life in blood
• Average trough value of blood clotting activity (lowest value), 12% (once age 12 years) with administration once every 2 weeks
• Median bleeding (AsBR), median number of annual bleeds is 0 (12 years or older)
• Prevention and improvement of joint disorders are expected due to high bleeding preventive effect
Today, CSL Behring Co., Ltd. (Headquarters: Koto Ward, Tokyo, President and Representative Director: Jean Marc Moranju) announced today that on November 29, Genetic Modified Blood Coagulation Factor IX Albumin Fusion Protein Formulation, Hemophilia B Treatment Preparation We are pleased to inform you that "Idealbion® for intravenous injection 250, 500, 1000, 2000" (hereinafter, Ideerbion®) has been released.
IDERBION ® is a half-life extended recombinant blood coagulation Factor IX albumin fusion protein preparation adapted for "suppression of bleeding tendency in patients with blood coagulation factor IX deficiency." The world's first proprietary technology to combine albumin known for its long biological half-life with blood coagulation Factor IX at the gene level has realized sustained high blood coagulation Factor IX activity over a long period of time.
Haemophilia is a disease that is difficult to stop blood when bleeding, which causes various restrictions and difficulties in daily life due to internal bleeding such as joints and muscles, intracranial bleeding, and the like. Also, as symptoms progress, there are also onset of joint disorder. Therefore, depending on the patient's symptoms and lifestyle, there are cases such as refraining from active activity due to anxiety about bleeding.
Treatment of haemophilia is mainly supplementary therapy that supplements missing blood coagulation factors with blood products, regularly maintaining the activity of blood coagulation factors by regularly administering the formulation to prevent bleeding beforehand Replacement therapy is commonly practiced. For conventional formulations, injections of 2 to 4 times per week, dosing intervals of about once every 10 days are required, which was the burden of patients and their families.
Ideerbion ® maintains a high average trough value of 12% at dosing intervals of 14 days, confirming the effect not found in the conventional formulation that the median value of natural bleeding (AsBR) and joint hemorrhage is 0 . Due to this high bleeding preventive effect, it is anticipated that burden by frequent injections will be reduced and joint disorder prevention / improvement will be anticipated, so the release in Japan as a new treatment option was awaited.
Jean Marc Moranju, President and Representative Director of CSL Bearing Co., Ltd. "Idealbion ® is one of the innovative products produced by years of R & D efforts to treat hemorrhagic diseases in the 100-year history of CSL . This product, as a preparation that can support the more active life of patients, reduce burden from frequent injections, and prevent arthropathy, patients, their families, health care workers I am convinced that it will be an important treatment option for patients. "
Product overview of IDERBION ®
Ideerbion ® for intravenous injection 250/500/1000/2000
Albre trepe nonacoag alpha (genetical recombination)
Application category New medicine containing active ingredients
Indication or effect
Suppression of bleeding tendency in blood coagulation factor IX deficient patients
CSL Bearing Co., Ltd.
Manufacturing marketing approval acquisition date: September 28, 2016
Iderbion ® for intravenous injection 250
Ideerbion ® for intravenous injection 500
Iderbion ® for intravenous injection 1000
Iderbion ® for intravenous injection 2000
Drug price criteria
November 18, 2016
Approval abroad Approved in USA, European Union, Switzerland, Canada and Australia
About hemophilia B
Haemophilia B (blood coagulation factor IX deficiency) is a hereditary hemorrhagic disease, it takes time to stop the hemostasis due to deficiency or loss of function of blood clotting factor IX, and it is difficult to treat it in the joint, muscle, or brain Symptoms such as spontaneous bleeding are seen. Hemophilia B is mostly a disease found in males, domestic statistics are affected by 1 to 2 people per 100,000 men and the number of patients is about 1000 people.
About CSL Bearing Co., Ltd.
Global company of biological products, Japan corporation of CSL Bering (head office: USA). We are focusing on the hemophilia area, critical care and hemostasis area, immune and rare disease area, we will contribute to medical treatment in Japan by stably supplying highly innovative formulation with world standard safety. In August 2016, we applied for domestic approval of prothrombin complex formulation (BE1116) which corrects the anticoagulant state of patients receiving treatment of vitamin K antagonist (warfarin etc) by treatment / prevention of thromboembolism.