Novartis Promacta receives FDA breakthrough designation for new indication

ZURICH: 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 drugmaker said.

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.