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.
Breakthrough status is a designation given to treatments
demonstrating substantial improvement over existing therapies in
treating a serious or life threatening illness.
Novartis said it expects regulatory filings in both the United
States and the European Union this year.
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(Reporting by Brenna Hughes Neghaiwi; Editing by Maria Sheahan)
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