Novartis: wins FDA breakthrough therapy for severe anemia
(CercleFinance.com) - Novartis has received breakthrough therapy designation from the FDA for Promacta to be used as first-line treatment in severe aplastic anemia, a rare blood disorder.
The US Food and Drug Administration has granted the designation for use in combination with standard immunosuppressive therapy, the Swiss drugmaker said on Thursday.
Promacta has already been approved as a second-line therapy in the refractory setting in severe aplastic anemia.
Severe aplastic anemia patients' bone marrow fails to produce enough red blood cells and white blood cells, causing fatigue, breathing difficulties and recurrent infections.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
The US Food and Drug Administration has granted the designation for use in combination with standard immunosuppressive therapy, the Swiss drugmaker said on Thursday.
Promacta has already been approved as a second-line therapy in the refractory setting in severe aplastic anemia.
Severe aplastic anemia patients' bone marrow fails to produce enough red blood cells and white blood cells, causing fatigue, breathing difficulties and recurrent infections.
Copyright (c) 2018 CercleFinance.com. All rights reserved.