ReutersZURICH, Jan 4 (Reuters) - Novartis drug Promacta has received breakthrough therapy designation from the U.S. Food and Drug Administration for first-line treatment of severe aplastic anemia (SAA).
The drug has received the designation for use in combination with standard immunosuppressive therapy in treating the rare blood disorder in which a patient's bone marrow fails to produce enough red blood cells, white blood cells and platelets, the Swiss drug maker said on Thursday.
Promacta is already approved as a second-line therapy in SAA, as well as for adults and children with chronic immune thrombocytopenia.
Novartis said it expects regulatory filings in both the United States and the European Union this year.
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