Novartis’ eltrombopag receives FDA BT designation for first-line use in SAA

The Food and Drug Administration (FDA) grants Breakthrough Therapy (BT) designation to eltrombopag (Promacta/Revolade, Novartis) for use in combination with standard immunosuppressive therapy for the treatment of patients with severe aplastic anemia (SAA) as a first-line therapy. Eltrombopag is already approved in the US and in the European Union for the treatment of thrombocytopenia in pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia who have had an insufficient response to corticosteroids and immunoglobulins.

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