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    Home > Active Ingredient News > Drugs Articles > Novo Nordisk has submitted the license application for the new long-acting hemophilia drug n8-gp to FDA and EMA respectively

    Novo Nordisk has submitted the license application for the new long-acting hemophilia drug n8-gp to FDA and EMA respectively

    • Last Update: 2018-03-08
    • Source: Internet
    • Author: User
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    Recently, Novo Nordisk announced that it has submitted the BLA and MAA of n8-gp, a new long-acting hemophilia drug, to the FDA (http:// and the EMA (http:// respectively About n8-gp n8-gp is a half-life extended coagulation factor VIII product (http:// which is used for the treatment of hemophilia A a N8-gp is a recombinant clotting factor VIII product in the form of glycosyl PEGylation novoeight (turotocog alpha), which is developed for the treatment of hemophilia A A patients Glycosyl PEGylation can prolong the circulating half-life of recombinant coagulation factor VIII, thus reducing the number of intravenous administration and the frequency of bleeding attack The glycosylated PEGylation site of n8-gp is located in the B domain truncated by turoctocog alfa N8-gp is a B-domain modified turoctocog alfa, so the active factor VIII produced by thrombin activation is the same as the activated endogenous FVII and turoctocog alfa The application documents of relevant research are submitted based on the data of phase III clinical project Pathfinder The project has enrolled more than 250 patients with type a blood disease, and evaluated the efficacy and safety of n8-gp in adult patients, children patients' on-demand treatment, preventive treatment and surgical hemostasis In the adult study, the median annual bleeding rate of patients receiving n8-gp prophylactic treatment every 4 days was 1.3 events, and the median bleeding rate of patients receiving on-demand treatment was 30.9 events In the pediatric study, the median annual bleeding rate for patients treated with n8-gp twice a week was 1.95 events In the study of operation, all operations can be carried out effectively after using n8-gp 43 of the 45 operations were evaluated as "excellent" or "good" Pharmacokinetic data showed that the single dose half-life of n8-gp was 18.4 hours, and the mean trough level of n8-gp was 4% in the preventive treatment group before the next dose In terms of safety, n8-gp showed good tolerance and safety across the clinical program of Pathfinder  
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