FDA approves application for license for complementary biologics at Romiplostim

recently, biotech giant Amgen announced that the U.SFood andDrug(http://Administration (
FDA(http://) has approved nplate's (http:// application for a supplementary biologic license (sBLA) for immunoglostolet reduction disorder (ITP) for at least six months and for patients 1 years and older who have insufficient response to corticosteroids, immunoglobulins or spleen removalAbout Nplate
Nplate is a platelet-based production hormone (TPO) receptor agonist that mimics the body's natural TPO and is designed to increase platelet counts in ITP patientsin the United States, Nplate has previously been approved for use in adult PATIENTs with other drugs or surgical treatments that are poorIn the European Union, Nplate has been approved for adult patients with ITP, as well as for pediatric patients 1 years and older who have been ITP for at least 6 months and who have insufficient response to corticosteroids, immunoglobulins or spleen removalsTo date, Nplate has been approved by 67 countries worldwideThe studythis approval is based on two placebo-controlled studies (Phase III and Phase I/II studies) that assessed the efficacy and safety of Nplate's treatment of ITP pediatric patientsresults from the Phase III study, published in The Lancet, showed a significant increase in total platelet remission rates (71 percent vs 20 percent, p0.05) and significantly higher rates of persistent platelet remission (52 percent vs 10 percent, p 0.05) in the Nplate treatment group compared to the placebo groupAdverse The most common adverse reactions (incidence of 25%) in the Nplate treatment group included bruising, upper respiratory tract infections, and sore mouth and throat in the 2 studies