多发性硬化症药治疗奥瑞珠单抗获FDA突破性疗法认定

来源 :国际药学研究杂志 | 被引量 : 0次 | 上传用户:yxiande123
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罗氏药厂宣布其治疗原发进展型多发性硬化症的奥瑞珠单抗(ocrelizumab)获FDA突破性疗法认定。此症占多发性硬化症患者的10%,其特征是有明显残疾进展,而无明显的复发或缓解期,目前无批准的有效治疗药物。奥瑞珠单抗是人源化单抗,选择性地靶向CD20阳性B淋巴细胞。此细胞与多发性硬化脱髓鞘疾病中髓磷脂和轴突损伤密切相关。临床前研究表明,此药与B淋巴细胞表面的CD20蛋白结合,但不与干细 Roche Pharmaceuticals announced that its ocrelizumab for primary progressive multiple sclerosis has been recognized by FDA’s breakthrough therapy. This disease accounts for 10% of patients with multiple sclerosis, which is characterized by significant disability progression without significant recurrence or remission, there is currently no approved effective treatment. Orebizumab is a humanized monoclonal antibody that selectively targets CD20-positive B lymphocytes. This cell is closely associated with myelin and axonal damage in multiple sclerosis demyelinating diseases. Preclinical studies have shown that this drug binds to the CD20 protein on the surface of B lymphocytes but not to the fine
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