近日，Ocrevus(ocrelizumab 中文译名：奥美珠单抗[一年注射2次])注射剂第一个药物被美国食品和药物管理局（FDA）批准为原发性进展型多发性硬化的另一种治疗选择 ocrelizumab是一种静脉输注药物，6个月输注一次，每年只需输注2次，有望显著改善MS患者的依从性。PPMS是多发性硬化症（MS）的一种严重病程类型，自病程开始便持续恶化，无明显的复发或缓解期，预后最差。PPMS约占MS病例的10%，目前尚无任何药物获批治疗PPMS。RMS则是一种更常见类型的MS。 FDA的药品评价和研究中心的神经学产品部主任Billy Dunn，M.D.说：“多发性硬化对人的生命可能有深刻影响，” “这个治疗不仅为有复发MS患者提供另一种治疗选择，而且首次为那些有原发性进展型多发性硬化患者提供另一种治疗选择。” 突破性治疗指定，快速通道指定，和优先审评。 批准日期：2017年3月28日；公司：Genentech，Inc. OCREVUSTM(奥美珠单抗[ocrelizumab])注射液，为静脉使用 美国初次批准：2017 作用机制 不知道ocrelizumab在多发性硬化症发挥其治疗作用的精确机制，但是被假设涉及与CD20结合，在前-B和成熟B淋巴细胞上存在的细胞表面抗原。细胞表面与B细胞结合后，ocrelizumab导致抗体-依赖性细胞学细胞溶解和补体-介导溶解。 适应证和用途 OCREVUS是一个指向CD20细胞溶解抗体适用为有复发或原发进展性型的多发性硬化症患者的治疗。 剂量和给药方法 ● 首次剂量前要求乙型肝炎病毒筛选 ● 每次输注前用甲泼尼龙[methylprednisolone](或一种等同的皮质激素)和一种抗组织胺(如，苯海拉明[diphenhydramine])预先给药. ● 通过静脉输注给予OCREVUS o 开始剂量：300mg静脉输注，接着两周以后给予第二次300 mg静脉输注 o 随后剂量：600mg静脉输注每6个月 ● 给药前必须稀释 ● 期间密切地监视患者和输注后共至少一小时. 剂型和规格 ● 注射液：300mg/10mL(30mg/mL)在一个单次-剂量小瓶. 禁忌证 ● 活动性乙型肝炎病毒感染 ● 对OCREVUS危及生命输注反应史 警告和注意事项 ● 输注反应：对输注反应处理建议依赖于反应的类型和严重程度。永久地终止OCREVUS如发生一种威胁生命或禁用输液反应。 ● 感染：在有一个活动感染患者延迟OCREVUS给药直至感染被解决。用OCREVUS治疗期间和终止后建议不用活减低或活疫苗疫苗接种，直至B-细胞充分供应 ● 恶性病：用OCREVUS可能存在恶性病的风险增加，包括乳癌。 不良反应 最常见不良反应为: ● RMS(发生率 ≥10%和> REBIF)：上呼吸道感染和输注反应 ● PPMS(发生率 ≥10%和> 安慰剂)：上呼吸道感染，输注反应，皮肤感染，和下呼吸道感染. 在特殊人群中使用 ● 妊娠：根据动物数据，可能致胎儿危害。 供应/贮存和处置 OCREVUS(ocrelizumab)注射液是一种无防腐剂，无菌，透明或略微乳白色，和无色至浅褐色溶液作为含一个300mg/10mL(30mg/mL)单次-剂量小瓶纸盒供应(NDC 50242-150-01)。 贮存 OCREVUS小瓶在2°C–8°C(36°F–46°F)在外纸盒以避光保护。不要冻结或摇晃。 FDA Approves  Ocrevus (Ocrelizumab Injection) The U.S. Food and Drug Administration (FDA) has approved Ocrevus (ocrelizumab), a humanized monoclonal antibody designed to selectively target CD20-positive B cells as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis. About OCREVUS™ (ocrelizumab) OCREVUS is an investigational, humanised monoclonal antibody designed to selectively target CD20-positive B cells. CD20-positive B cells are a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage, which can result in disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved. The Phase III clinical development programme for OCREVUS (ORCHESTRA) includes three studies: OPERA I, OPERA II and ORATORIO. OPERA I and OPERA II are identical Phase III, randomised, double-blind, double-dummy, global multi-centre studies that evaluated the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion every six months) compared with interferon beta-1a (44 mcg administered by subcutaneous injection three times per week) in 1,656 people with relapsing forms of MS (i.e., relapsing-remitting MS and secondary-progressive MS with relapses).1 ORATORIO is a Phase III, randomised, double-blind, global multi-centre study that evaluated the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion every six months; given as two 300mg infusions two weeks apart) compared with placebo in 732 people with primary progressive MS (PPMS). About multiple sclerosis Multiple sclerosis (MS) is a chronic disease that affects an estimated million people around the world, for which there is currently no cure.MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the brain, spinal cord and optic nerves, causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including muscle weakness, fatigue and difficulty seeing, and may eventually lead to disability. Most people with MS experience their first symptom between 20 and 40 years of age, making the disease the leading cause of non-traumatic disability in younger adults. Relapsing MS is the most common form of the disease. Disease activity and progression can occur even when people do not show signs or symptoms of MS, despite available relapsing MS treatments. Primary progressive MS (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission.9 Approximately one in 10 people with MS are diagnosed with the primary progressive form of the disease. There are no approved treatments for PPMS. Ocrevus is administered by intravenous infusion every six months. The first dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions. Ocrevus U.S. Indication Ocrevus is a prescription medicine used to treat adults with relapsing or primary progressive forms of multiple sclerosis. It is not known if Ocrevus is safe or effective in children.