BioCentury
ARTICLE | Clinical News

Promacta eltrombopag regulatory update

June 22, 2015 7:00 AM UTC

FDA approved an sNDA from Novartis for Promacta eltrombopag to treat pediatric patients ages >=6 with chronic idiopathic thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. The small molecule thrombopoietin (TPO) receptor ( CD110; Mpl) is approved for the indication in adults. It is also approved in the U.S. to treat thrombocytopenia in patients with chronic HCV infection and to treat patients with severe aplastic anemia ( SAA) who have had an insufficient response to immunosuppressive therapy. ...