Revolade eltrombopag regulatory update

The European Commission approved Revolade eltrombopag from Novartis to treat severe aplastic anemia ( SAA) in adults who were either refractory to prior immunosuppressive therapy (IST) or heavily pretreated and are unsuitable for hematopoietic stem cell transplant (HSCT). The small molecule thrombopoietin (TPO) receptor ( CD110; Mpl) agonist is also approved in the EU to treat chronic idiopathic thrombocytopenic purpura (ITP) in splenectomized adult patients who are refractory to other treatments or in non-splenectomized adult patients where surgery is contraindicated. Earlier this year, the pharma submitted a regulatory application to EMA to include the treatment of chronic ITP in patients ages >=1 and for an oral suspension formulation.

Separately, FDA approved an sNDA from Novartis for Promacta to treat pediatric patients ages 1-5 with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. The agency also approved an oral suspension formulation of Promacta. The drug is approved for the indication in patients ages >=6 and is available as a tablet. It is also approved to treat SAA in patients who have had an insufficient response to IST. ...