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Thrombosis and Hemostasis

CHMP advocates approval of edoxaban product

HT Staff Read Article
Published: 02/26/17

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Thrombus
Image by Andre E.X. Brown

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Roteas receive marketing authorization for the same indications as Lixiana. Both Roteas and Lixiana are oral factor Xa inhibitors that contain the active ingredient edoxaban. The CHMP has recommended approving Roteas for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults. [Read Article]

Using mRNA to treat hemophilia B

HT Staff Read Article
Published: 02/17/17

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Lab mouse

Researchers have reported the successful treatment of hemophilia B in mice using messenger RNA (mRNA). In experiments, protein-replacement therapy using mRNA was effective longer than recombinant factor IX (FIX) therapy. The mRNA therapy also appeared to be safe and produced mild, transient immune responses. In addition, the researchers noted that the mRNA therapy can be produced more cheaply than recombinant FIX therapy. [Read Article]

Therapy shows promise for treating hemophilia B

HT Staff Read Article
Published: 02/14/17

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Irish setter, a breed of dog
that can develop hemophilia B

A plant-made therapy has demonstrated safety and efficacy in dogs with hemophilia B, according to research published in Molecular Therapy. Previously, researchers found they could produce freeze-dried lettuce cells expressing human coagulation factor IX (FIX) fused with cholera toxin B subunit (CTB). These cells were able to prevent inhibitor formation and allergic reactions to intravenous FIX therapy in mice with hemophilia B. [Read Article]

FDA approves IVIG product for PI and chronic ITP

HT Staff Read Article
Published: 02/09/17

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Vials of product
Photo by Bill Branson

The US Food and Drug Administration (FDA) has approved an intravenous immunoglobulin (IVIG) product (Gammaplex® 10%) for the treatment of primary immunodeficiency (PI) and chronic immune thrombocytopenia (ITP) in adults. PI includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked and congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. [Read Article]

Therapy demonstrates safety, efficacy in kids with hemophilia B

HT Staff Read Article
Published: 02/06/17

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Eftrenonacog alfa
Photo courtesy of Biogen

Eftrenonacog alfa, a recombinant factor IX Fc fusion protein, has produced favorable results in children with severe hemophilia B, researchers have reported. The team said eftrenonacog alfa was generally well-tolerated in the phase 3 Kids B-LONG study, and none of the patients on this trial developed inhibitors. In addition, the annualized bleeding rate was low, and most patients were able to maintain once-weekly dosing. [Read Article]

 

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