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Bayer type A hemophilia new drug submitted for marketing in Japan
Pharmaceutical Network October 19th German pharmaceutical giant Bayer (Bayer) recently announced that it has submitted long-acting, site-specific PEGylated recombinant human factor VIII (PEG-rFVIII) product BAY94-9027 (damoctocog) to Japanese regulators Alfa pegol) A biological product license application (BLA) for the treatment of hemophilia A, which is PEGylated at a specific site and therefore has an extended blood half-life.
The submission of this regulatory document is based on positive data from the Phase III study PROTECT VIII. The results of this study showed that BAY94-9027 had a good prophylactic effect when it was administered once every 7 days, once every 5 days, twice a week. In addition, BAY94-9027 can also effectively control bleeding events during surgery and effectively treat all bleeding events, in most cases only intravenous infusion or once.
Currently, the standard care for hemophilia A is clotting factor VIII replacement therapy, which requires regular infusion and maintains sufficient VIII levels high enough to prevent bleeding. In view of the short half-life of VIII products currently on the market, prophylactic administration may require frequent administration, usually every other day or three times a week.
BAY94-9027 is designed to insert a cysteine ​​residue (Cys) on the surface of recombinant human factor VIII protein and use it as an attachment site for polyethylene glycol (PEG) polymer to achieve extended half-life. Objective, while retaining the biological activity of rFVIII.
Hemophilia A is also known as factor VIII deficiency or classic hemophilia, which is a recessive hereditary hemorrhagic disease caused by an X-linked chain clotting factor VIII or abnormal molecular structure, which is common in men . Hemophilia A is usually caused by a deficiency of factor VIII in the body, which is characterized by the inability of the patient's blood to coagulate normally, resulting in uncontrolled and frequent persistent or spontaneous bleeding, especially bleeding into joints, muscles or other tissues, leading to chronic joints. damage. External injuries, even minor ones, can cause serious consequences. The clotting time was significantly prolonged in patients with hemophilia A compared with normal subjects. It is estimated that the incidence of hemophilia A is about 5,000, about 30,000 patients in Europe, about 14,000 in the United States, and about 5,000 in Japan.
In the past few decades, the clinical treatment of hemophilia has made great progress, and the life expectancy of patients has increased from 11.4 years in 1920 to the life expectancy of normal people. At present, the research goal in the field of hemophilia is mainly to reduce the burden of treatment and provide quality of life for patients.