Posted by Michael Wonder on 17 Nov 2018
FDA approves Novartis drug Promacta for first-line SAA and grants breakthrough therapy designation for additional new indication
16 November 2018 - Promacta receives FDA approval for first-line treatment of severe aplastic anaemia and breakthrough therapy designation for low platelet counts in people exposed to radiation.
Novartis announced today that the US FDA has expanded the label for Promacta (eltrombopag) to include first-line treatment for adults and paediatric patients two years and older with severe aplastic anaemia in combination with standard immunosuppressive therapy (IST).
The FDA's approval is based on Novartis' analysis of research sponsored by the National Heart, Lung and Blood Institute (NHLBI) Division of Intramural Research Program and conducted under a Cooperative Research and Development Agreement (CRADA). The study showed that 44% (95% CI 33, 55) of definitive IST-naive SAA patients achieved complete response at 6 months when treated with Promacta concurrently with standard IST, which was 27% higher than the complete response rate historically observed with the standard IST alone. The overall response rate was 79% (95% CI 69, 87) at 6 months.
