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Pharmaceuticals / Submissions and Approvals

FDA Clears Novartis’ Promacta for First-Line Severe Aplastic Anemia

Nov. 27, 2018
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The FDA approved an expanded label for Novartis’ Promacta (eltrombopag) to include first-line treatment for adults and pediatric patients aged two and older with severe aplastic anemia (SAA) in combination with standard immunosuppressive therapy (IST).

The rare, life-threatening blood disorder hampers the patient’s bone marrow’s ability to produce red blood cells, white blood cells and platelets.

The oral thrombopoietin receptor agonist is already approved for SAA for patients that exhibited an insufficient response to IST, as well as adults and children with chronic immune thrombocytopenia who are refractory to other treatments, and for treating thrombocytopenia in patients with hepatitis C virus infections.

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