FDA approves Novartis immunotherapeutic drug Promacta for use in ITP pediatric patients
FDA approves Novartis immunotherapeutic drug Promacta for use in ITP pediatric patients June 16, 2015 Source: Bio Valley The $22 billion asset swap transaction between the two giants of the pharmaceutical industry, Novartis and GlaxoSmithKline (GSK), was successfully completed in early March. Among them, Novartis acquired GlaxoSmithKline's oncology business for $16 billion, bringing it to the second place in the global cancer treatment field, second only to the oncology giant Roche. Recently, the immunotherapeutic drug Promacta (eltrombopag, Elchepopa) has received good news in the regulation. The FDA has approved the expansion of the drug for glucocorticoids, immunoglobulins or splenectomy. Treatment of pediatric patients with idiopathic thrombocytopenic purpura (ITP) 6 years of age and older with poor response. Previously, the FDA approved Promacta for the same indications for adult patients in 2008. The incidence of ITP in the children's population is five in 100,000, and the disease is characterized by low platelet counts. About 30% of pediatric patients are chronic ITP, and the risk of severe bleeding is significantly elevated. Promacta was approved based on two double-blind, placebo-controlled studies, including the largest phase III study in the pediatric population. The data show that Promacta can increase and maintain platelet counts in chronic ITP pediatric patients; at the same time, Promacta can reduce or stop the use of ITP drugs for patients taking ITP drugs. It should be noted that Promacta should be used only for patients with thrombocytopenia and patients whose clinical severity increases the risk of bleeding. Eltrombopag, developed by GlaxoSmithKline, is a once-a-day oral thrombopoietin (TPO) receptor agonist that promotes platelet levels in the blood by inducing proliferation and differentiation of bone marrow stem cells. Currently, etrombopag has been approved by more than 100 countries worldwide for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP), and has been approved for use in chronic C in 43 countries. Hepatitis (CHC) patients are treated for thrombocytopenia in order to initiate and maintain an interferon-based standard therapy for liver disease. In August 2014, the FDA further approved etrombopag for the treatment of cytopenia in patients with severe aplastic anemia (SAA) who were underreactive to immunosuppressive therapy (IST). The drug is sold under the trade name Promacta in the United States and Revolade in Europe and other countries. (Bio Valley Bioon.com) Source: Novartis gains FDA approval for Promacta providing new option for children, ages 6 and older, with chronic ITP, a rare blood disorder Shrimp Series,Wild Shrimp,Frozen Pink Shrimp,Frozen Vannamei Shrimp Zhejiang Zhoushan Jiaze Aquatic Co., Ltd. , https://www.tianjia-aquatics.com