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1.引言 Genentech公司开发的奥马单抗(omalizumab/Xolair)已于2003年6月获得美国食品与药品管理局批准,用于使用吸入皮质激素制剂仍不能适当控制症状的12岁及其以上中至重度持续性变应性哮喘患者治疗。奥马单抗属单克隆抗体药物,它具有能与变应反应关键介质免疫球蛋白E特异性结合、进而阻断变应反应级联并由此显现抗哮喘效应的新颖作用机制。奥马单抗的获准上市无疑将推动哮喘治疗市场的进一步扩展,而其本身亦能在这一进程中逐渐成长成为一个“重磅炸弹”级新药。
1. INTRODUCTION Genentech’s omalizumab / Xolair was approved by the U.S. Food and Drug Administration in June 2003 for use in patients 12 and older who are still unable to properly control symptoms using inhaled corticosteroids Severe persistent allergic asthma patients. Omazumab is a monoclonal antibody drug that has a novel mechanism of action that specifically binds immunoglobulin E, a key mediator of allergic reactions, thereby blocking the allergic cascade and thereby exhibiting anti-asthmatic effects. The approved listing of OMA will undoubtedly promote the further expansion of the asthma treatment market, which itself can gradually grow into a “blockbuster” new drug in the process.