Promacta Designated Breakthrough Therapy for Severe Aplastic Anemia
Ligand Pharmaceuticals announced that the FDA has granted Breakthrough Therapy designation for Promacta (eltrombopag; GlaxoSmithKline) for the treatment of cytopenias in patients with severe aplastic anemia (SAA) who have had insufficient response to immunosuppressive therapy.
Promacta is a thrombopoietin receptor agonist currently indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Also, it is indicated for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.
The Breakthrough Therapy designation was based on the results from an open-label, Phase 2 National Institute of Health study (09-H-0154) of eltrombopag in heavily pre-treated SAA patients (n=43) with an insufficient response to initial immunosuppressive therapy.
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