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    Home > Medical News > Latest Medical News > A new hemophilia drug! The long-acting Novo Nordisk drug esperoct is on the market in the United States, with longer half-life and fewer injections!

    A new hemophilia drug! The long-acting Novo Nordisk drug esperoct is on the market in the United States, with longer half-life and fewer injections!

    • Last Update: 2020-02-18
    • Source: Internet
    • Author: User
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    Author: Recently, Novo Nordisk announced that esperoct (turotocog Alfa pegol, n8-gp) has been sold in the United States for adult and child patients with hemophilia A A: (1) routine preventive treatment to prevent or reduce the frequency of bleeding episodes; (2) treatment and control of bleeding episodes on demand; (3) perioperative bleeding management In the United States, esperoct was approved by FDA in February 2019, but due to the third-party intellectual property agreement, Novo Nordisk is unable to launch esperoct in the U.S market before 2020 Hemophilia A A is a chronic, hereditary bleeding disease that affects nearly 20000 people in the United States It is also known as factor VIII deficiency or classic hemophilia It is an X-linked genetic disease caused by the deficiency or defect of coagulation factor VIII The patient will have continuous or spontaneous bleeding repeatedly, especially in joints, muscles or internal organs, which can lead to disability for a long time It is estimated that about 60% of hemophilia A A is a serious disease At present, the nursing standard of severe hemophilia A is the preventive treatment plan of intravenous infusion of coagulation factor VIII 2-3 times a week Esperoct is a clotting factor VIII product with a longer half-life Compared with standard half-life factor VIII product, esperoct has a 1.6-fold longer half-life in adult / adolescent patients and a 1.9-fold longer half-life in children Esperoct can help patients with hemophilia A maintain higher levels of coagulation factor VIII for longer periods of time than standard half-life VIII products that require multiple intravenous infusions, which will help reduce the frequency of bleeding and the number of administration Esperoct's approval is based on the data of Pathfinder, the largest and longest clinical project in hemophilia A, with 5 cross-border studies involving 270 patients The project evaluated the efficacy and safety of esperoct in adult patients, children patients on-demand treatment, preventive treatment, surgical hemostasis The results showed that esperoct could provide effective routine prevention in severe hemophilia A patients (endogenous FVII activity < 1%) through a simple, fixed dose regimen (once every 4 days for adults and adolescents, once every 3-4 days [twice a week] for children) In adults and adolescents (≥ 12 years old), esperoct can provide effective preventive effect and maintain the annual average bleeding rate (ABR) as low as 1.18 events when it is given 50 IU / kg every 4 days In children under 12 years of age, the median ABR was 1.95 when esperoct was administered twice a week at a dose of 60 IU / kg (50-75 IU / kg) In addition, esperoct was shown to be equally effective in the treatment and control of bleeding events and perioperative management Across all studies and age groups, esperoct was well tolerated and no safety issues were identified The overall safety of esperoct is similar to other long-term FVII products reported Esperoct (n8-gp) is a glycosylated form of recombinant coagulation factor VIII product novoeight (turocog 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 Novoeight is the trade name of the third generation recombinant coagulation factor VIII product turoctocog alpha of Novo Nordisk, which was approved by FDA and EU in 2013 It is used for the preventive treatment and on-demand treatment of hemophilia A A patients The product uses the latest gene recombination and protein purification technology Novo Nordisk launches esperoct in the U.S for the treatment of people with hermophilia a
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