Novartis’ Promacta receives FDA breakthrough designation for new indication


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.

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.


(Reporting by Brenna Hughes Neghaiwi; Editing by Maria Sheahan)


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