Posted by Michael Wonder on 30 May 2018
FDA expedites review of Novartis drug Promacta for first-line severe aplastic anaemia
30 May 2018 - Regulatory action underscores the treatment potential of Promacta for a rare and serious blood condition.
Novartis announced today that the US FDA has accepted the company's supplemental new drug application and granted priority Review designation to Promacta (eltrombopag) in combination with standard immunosuppressive therapy (IST) for first-line treatment of severe aplastic anemia (SAA).
The priority review for first-line SAA is based on Novartis' analysis of research sponsored by the Intramural Research Program of the National Heart, Lung, and Blood Institute of the National Institutes of Health and conducted under a Cooperative Research and Development Agreement. The study showed that more than half (52%) of treatment-naïve SAA patients achieved complete response at six months when treated with Promacta concurrently with standard IST, which was an increase of 35% compared to those treated with the standard IST alone. The overall response rate was 85% at six months.
