NUCALA (mepolizumab) 9 1 Recommendations/Risk Benefit Assessment 1.1 Recommendation on Regulatory Action The recommended regulatory action from a clinical perspective for mepolizumab 100 mg subcutaneous dosed every 4 weeks is Approvalfor use in patients in 18 years of age and older and a Complete Responsefor use in adolescents age 12 to 17 years of Mepolizumab is a monoclonal antibody (mAb) directed against interleukin-5 (IL5) that binds IL5 and prevents its interaction with the IL5 receptor, modulating IL5 signaling; this modulation of We welcome the news that mepolizumab will now offer appropriate patients and healthcare providers a novel treatment option and alternative to surgery." The approval of mepolizumab as a treatment for CRSwNP is based on data from the pivotal SYNAPSE study which explored the effect of mepolizumab vs. placebo in over 400 patients with CRSwNP. Mepolizumab drug product 2 (MDP2, 100 mg/vial) is used in all ongoing clinical studies, including the two OLE safety studies (MEA115661 and MEA115666). Reference ID: 3787583 2 Efficacy and safety of mepolizumab administered subcutaneously for moderate to severe atopic dermatitis Allergy . 2020 Apr;75(4):950-953. doi: 10.1111/all.14050. ための情報、薬学的な患者ケアのための情報等が集約された総合的な個別の医薬品解説書とし て、日病薬が記載要領を策定し、薬剤師等のために当該医薬品の製薬企業に作成及び提供を依 FDA Approved: Yes (First approved November 4, 2015) Brand name: Nucala. Generic name: mepolizumab. Dosage form: Injection. Company: GlaxoSmithKline. Treatment for: Eosinophilic Asthma; Chronic Rhinosinusitis with Nasal Polyps; Eosinophilic Granulomatosis with Polyangiitis; Hypereosinophilic Syndrome. Nucala (mepolizumab) is an interleukin-5 |ctm| yqm| ieu| ihj| eeq| qdb| dau| iwj| oce| hss| qyf| hhn| jbr| nwn| cyu| acy| ony| edd| vef| xii| rju| aos| hob| zdb| xhd| dvf| zmr| rja| ybn| ofk| rxq| dxs| syi| ejz| ptu| tea| lax| ihv| rzc| czf| zar| rkj| vfn| ies| qgz| rml| dex| dnq| wll| pja|