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Friday, June 28, 2019

European advisory group rejects expanded label for Novartis’ Revolade

The European Medicines Agency’s advisory group CHMP has adopted a negative opinion against approval for Novartis’ (NYSE:NVS) Revolade (eltrombopag) for treatment-naive patients at least two years old with severe aplastic anemia.
Revolade is currently approved in the EU for adults with severe aplastic anemia, HCV-positive adults with thrombocytopenia (low blood platelets) and patients at least one year old with immune thrombocytopenia.

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