FDA Approves Novartis Drug Promacta for New Indications

   By Stephen Nakrosis 
 

Novartis AG (NVS) said Friday the U.S. Food and Drug Administration approved its drug Promacta for patients with a rare, life-threatening, acquired blood disorder and also gave it Breakthrough Therapy designation for low platelet counts in people exposed to radiation.

The FDA's approval of Promacta for first-line treatment of severe aplastic anemia, or SAA, was based on Novartis' analysis of research sponsored by the National Heart, Lung and Blood Institute Division of Intramural Research Program. Data showed a "compelling benefit established through complete response rates among SAA patients when Promacta is added to standard immunosuppressive therapy relative to historic information on that therapy alone," the company said.

Promacta is the first new treatment in decades for newly diagnosed SAA patients in the U.S., Novartis said, adding a decision by the European Medicines Agency is expected in 2019.

The FDA also granted Promacta Breakthrough Therapy designation as a counter measure for hematopoietic sub-syndrome of acute radiation syndrome, or H-ARS. Research and development of Promacta for H-ARS is being conducted under contract with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority.

-Write to Stephen Nakrosis at [e-mail]

(END) Dow Jones Newswires

November 16, 2018 17:22 ET (22:22 GMT)

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