FDA accepts Coagadex's application for license to supplementary biologics
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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recently, Bio Products Laboratory (BPL)(announcing that the U.SFDA( has accepted the company's application for a supplementary biologic license (sBLA) for Coagadex and granted it priority review eligibilitycoagadexCoagadex is a coagulation factor X concentrate extracted from plasma, a preventive therapy for the treatment of hereditary factor X deficiency (hereditary factor X deficiency, FXD) and can be used in FXD patients under the age of 12Coagadex is a factor X concentrate purified from plasma that isproduct developed specifically for the treatment of FXDMore than 94% of the components in the concentrate are factor X, while other coagulation factors (factor II and factor IX) have few componentsTherefore, Coagadex does not increase the level of other coagulation factors while supplementing coagulation factor X in patients with FXD, which helps prevent thrombosis caused by high levels of other coagulation factorsCoagadex has been approved by the FDA for use in adults and children over 12 years of age to control bleeding events and to help FXD patients control the risk of surgical bleedingrelated studies
this sBLA submission is based on the results of an open label, non-random, multicenter, prospective Phase 3 clinicaltrialcalled TEN02In this trial, nine patients with moderate or severe FXD under the age of 12 were treated with CoagadexAs a preventive therapy, patients initially receive Coagadex treatment twice a week at a dose of 40-50 IU/kg body weight In order to adjust the level of factor X in the patient's blood to more than 5 IU/dL (and a peak of less than 120 IU/dL), the frequency and dose of treatment in the patient can be adjusted during the first 6 weeks after the start of the trial results show edgtoex can reduce the frequency of bleeding in all patients treated, or completely eliminate bleeding events during the trial At the same time, during the 26-week trial, the level of factor X in the patient's blood was maintained above 5 IU/dL after the last dose adjustment safety
no patient sproduceas an inhibitor of factor X, and no patient dies as a result of treatment The side effects of the patient during the trial were not related to the therapy
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