Factor IX product launched in US

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Rebinyn vials
Photo from Novo Nordisk
The recombinant, GlycoPEGylated coagulation factor IX product Rebinyn® is now available in the US for the treatment of patients with hemophilia B. Last May, Rebinyn was approved by the US Food and Drug Administration for on-demand treatment and control of bleeding episodes as well as perioperative management... [Read Article]
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IV bevacizumab improves severe bleeding in HHT

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Mucocutaneous telangiectasias
at baseline (left) and after
3 doses of IV bevacizumab
Photo courtesy of
Mayo Clinic Proceedings
Intravenous (IV) bevacizumab “dramatically” improves severe bleeding associated with hereditary hemorrhagic telangiectasia (HHT), according to researchers. In a retrospective study, HHT patients with severe bleeding had a substantial reduction in nose bleeds and gastrointestinal (GI)... [Read Article]
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CHMP recommends approval of emicizumab

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Emicizumab (Hemlibra)
Photo from Business Wire
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of emicizumab (Hemlibra®), a bispecific factor IXa- and factor X-directed antibody. The recommendation is for emicizumab to be used as routine prophylaxis in patients of all ages who have hemophilia A with... [Read Article]
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Low inhibitor rate observed in PUPs with hemophilia A

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Antihemophilic factor
Researchers have observed a low inhibitor rate in previously untreated patients (PUPs) with severe hemophilia A who received treatment with Octanate®. The study included 51 PUPs who received octanate, a plasma-derived, von Willebrand factor-stabilized coagulation factor VIII (FVIII) concentrate. Five of these patients (9.8%) developed FVIII inhibitors, all of whom were... [Read Article]
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EC approves product to treat hemophilia A

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Vial of Adynovate, the US
version of Adynovi
Photo courtesy of Baxalta
The European Commission (EC) has granted marketing authorization for rurioctocog alfa pegol (Adynovi). Rurioctocog alfa pegol (formerly BAX 855) is a pegylated, full-length, recombinant factor VIII product built on a previously licensed recombinant factor VIII product (Advate). Rurioctocog alfa pegol is now... [Read Article]
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