Главная » 2015 » Май » 19 » FDA Approves Recombinant Porcine-Sequence Element VIII
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FDA Approves Recombinant Porcine-Sequence Element VIII
FDA on October 23 approved recombinant porcine-sequence antihemophilic piece, or Obizur, for the treatment of bleeding episodes in adults with acquired hemophilia A.
Patients with acquired hemophilia A, the mechanism said, give rise to coagulation determinant VIII and also autoantibodies to it. These autoantibodies inactivate the coagulation particular, preventing patients' blood from clotting normally.
According to the labeling (PDF) for Obizur, the output's porcine-sequence antihemophilic part achieves hemostasis before in carrying out the activity of the coagulation factor VIII that has been inactivated via autoantibodies.
A porcine plasma–derived antihemophilic aspect that had been close by in the interest of patients with acquired hemophilia A is in little stock, if available at all, because of concerns around the porcine plasma, according to a keynoter at a 2003 workshop convened by means of FDA.
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