Novartis’ Promacta Receives FDA Breakthrough Designation for New Indication

Novartis’ Promacta Receives FDA Breakthrough Designation for New Indication

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Novartis' logo is seen in Stein
Swiss drugmaker Novartis' logo is seen at the company's plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann

ZURICH (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.

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)