GlaxoSmithKline submitted the BLA application of mepirizumab to Europe and America

On November 5, 2014, GSK, a pharmaceutical company, announced that it had submitted its registration application for maintenance treatment of eosinophilic asthma with mepirizumab to drug regulatory agencies in the United States and Europe The criteria for judging eosinophilic asthma are at least 150 cells / μ l eosinophils in peripheral blood screening or at least 300 cells / μ l eosinophils in peripheral blood in a certain period of the previous year Among the applications submitted this time are: to submit to the US Food and drug administration the application for biologicals license for maintenance therapy (BLA) for the use of mepirizumab in patients aged 12 and over who have severe eosinophilic asthma and have a history of acute attack Submit to the European drug administration an application for marketing permission for the maintenance treatment of mepirizumab for adults with severe eosinophilic asthma who have a history of acute attack or / or who rely on glucocorticoid systemic therapy Mepirizumab is a monoclonal antibody, which is injected subcutaneously at a dose of 100mg every four weeks The application submitted to the United States and Europe is based on a phase III clinical study of mensa1 and sirius2 published in the New England Medical Journal in September 2014 and the previous IIb / iiidream3 (experimental name) study published in the lancet (medical journal published by Elsevier publishing company in the UK) in 2012 Mensa and Sirius both studied patients with a blood eosinophil count higher than a predetermined level of 150 cells / microliter or who had a eosinophil count of more than 300 cells / microliter in the past 12 months Dave Allen, a research expert in the field of respiratory therapy, said: "severe asthma has a serious harm to the patient's body, which can cause the patient's eosinophil level to increase, and it can't be controlled by taking medicine." It's very difficult to have a treatment plan for this disease, and through the documents submitted to the regulatory agency today, we are making progress towards the use of mepirizumab in the treatment of these refractory diseases " The company plans to apply to other international companies from 2014 to 2015 The use of mepirizumab has not been approved by any country at the present time (from 5387896)