FDA Approves Novartis Drug Promacta for New Indications
17 November 2018 - 9:37AM
Dow Jones News
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 stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
November 16, 2018 17:22 ET (22:22 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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