EC approves product for hemophilia A

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Damoctocog alfa pegol (Jivi)
Photo from Bayer
The European Commission (EC) has approved damoctocog alfa pegol (Jivi®), a recombinant human factor VIII therapy. Damoctocog alfa pegol (formerly BAY94-9027) is approved for the treatment and prophylaxis of bleeding in previously treated patients age 12 and older who have hemophilia A. The approval is valid in... [Read Article]
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Score can predict thrombosis in ITP

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Thrombus
Image by Andre E.X. Brown
New research suggests a scoring system can predict the risk of thrombosis in patients with immune thrombocytopenia (ITP) who are taking anticoagulants. Researchers tested their Thrombosis and Thrombocytopenia (TH2) risk assessment score in a small group of ITP patients on anticoagulants, and the score identified all seven patients... [Read Article]
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Canada approves Jivi for hemophilia A

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U.S. version of Jivi®
Photo from Bayer
Health Canada has approved Jivi® (antihemophilic factor [recombinant, B-domain deleted, PEGylated]) for use in patients with hemophilia A. Jivi (formerly BAY94-9027) is a DNA-derived, factor VIII concentrate developed by Bayer. Health Canada has approved Jivi for use as routine prophylaxis to prevent or reduce the frequency of... [Read Article]
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Inhibitor receives orphan designation for ITP

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Platelets (blue) surrounded by red blood cells
Image from Graham Beards
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to PRN1008 for the treatment of patients with immune thrombocytopenia (ITP). PRN1008 is an oral, reversible, covalent Bruton’s tyrosine kinase (BTK) inhibitor being developed by Principia Biopharma, Inc. Principia is conducting a... [Read Article]
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Variant not associated with CLL, AIHA, or ITP in certain patients

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DNA helix
Image by Spencer Phillips
New research suggests there is no association between the PTPN22 R620W polymorphism and chronic lymphocytic leukemia (CLL) or autoimmune hematologic disorders in patients from the Republic of Macedonia. Past studies have shown an association between the PTPN22 R620W variant and both CLL and autoimmune diseases in patients from... [Read Article]
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Emicizumab now also approved for hemophilia A without inhibitors

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Emicizumab (Hemlibra)
Photo from Business Wire
The U.S. Food and Drug Administration (FDA) approved emicizumab-kxwh (Hemlibra) for prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients, including newborns, with hemophilia A with or without factor VIII (FVIII) inhibitors. It was first approved in 2017 for hemophilia A patients with FVIII... [Read Article]
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CHMP recommends factor VIII therapy for hemophilia A

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U.S. version of damoctocog alfa pegol (Jivi®)
Photo from Bayer
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for damoctocog alfa pegol, a recombinant human factor VIII therapy. Bayer is seeking European marketing authorization for damoctocog alfa pegol (formerly BAY94-9027), for the treatment and prophylaxis of... [Read Article]
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Caplacizumab approved to treat aTTP

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Vials and a syringe
The European Commission has granted marketing authorization for caplacizumab (Cablivi™), a humanized bivalent nanobody that inhibits the interaction between von Willebrand factor and platelets. Caplacizumab is now approved to treat adults with acquired thrombotic thrombocytopenic purpura (aTTP) in all member countries of the European Union as well as Norway, Iceland, and... [Read Article]
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Factor VIII product approved for hemophilia A

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Antihemophilic factor
(recombinant)
PEGylated-aucl (Jivi®)
Photo from Bayer
The US Food and Drug Administration (FDA) has approved Jivi® (antihemophilic factor [recombinant] PEGylated-aucl) for the treatment of hemophilia A. Jivi (formerly BAY94-9027) is a DNA-derived, factor VIII concentrate approved for use in previously treated adults and adolescents (age 12 and older) with hemophilia A. The product... [Read Article]
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A new standard of care in hemophilia A?

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Emicizumab (Hemlibra)
Photo from Business Wire
Results of a phase 3 trial showed that prophylaxis with emicizumab significantly reduced bleeds, compared to no prophylaxis, in patients with hemophilia A without inhibitors. Emicizumab also reduced bleeds when compared to prior factor VIII prophylaxis. The most common adverse events (AEs) in this trial were injection site reactions,... [Read Article]
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