2023年 6 月 28 日，[中国，上海] —— 梯瓦中国（Teva）宣布，中国国家药品监督管理局（NMPA）于近日正式批准了「醋酸格拉替雷注射液」（固派松®、Copaxone®）。该药品适用于治疗复发型多发性硬化（MS）成人患者，包括临床孤立综合征、复发缓解型多发性硬化和活动性继发进展型多发性硬化。此次获批规格（20 mg/mL 和 40 mg/mL）均获得美国食品药品监督管理局（FDA）批准，其中，40 mg/mL 降低了每周给药频次，提高了患者依从性和便利性。
多发性硬化是一种免疫介导的中枢神经系统炎性脱髓鞘疾病，常见临床表现为反复发作的视力下降、复视、肢体感觉障碍、肢体运动障碍、共济失调、膀胱或直肠功能障碍等。据统计，全球约 280 万多发性硬化患者（2020 年）[1]，在中国的发病率为每年 0.235/10 万人，是除创伤外年轻成人永久残疾的最常见病因 [2]。
经典药物，兼顾疗效与长期安全性
醋酸格拉替雷是由 4 种天然氨基酸 L-谷氨酸、L-丙氨酸、L-酪氨酸和 L-赖氨酸组成的合成多肽的醋酸盐。作为治疗复发型多发性硬化成人患者的一线疾病修正治疗药物，醋酸格拉替雷注射液已在全球 50 多个国家获批，临床应用超过 27 年，疗效确切，具有良好的长期安全性和耐受性。
近 30 年的临床研究数据证实，醋酸格拉替雷可显著降低复发率和疾病活动性，改善患者残疾进展和脑萎缩，降低临床孤立综合征转归为多发性硬化的风险，同时还可改善疲劳、认知功能和痉挛等症状。此外，醋酸格拉替雷长期安全性良好，无明显时间依赖性的不良反应，非特殊情况无须监测 [3-16]。
聚焦育龄期患者，满足迫切临床需求
据统计，多发性硬化多发于青壮年，育龄期女性患者占比较高。有研究显示，部分女性患者因生育计划致疾病修饰治疗严重推迟，使残疾进展风险增加 [3-16]。对于有怀孕计划、出现意外怀孕或处于哺乳期的女性患者，现有治疗多采用停药处理，部分疾病修饰治疗药物甚至需要进行快速洗脱，可见育龄期患者的迫切临床需求并未被满足 [12-13]。
醋酸格拉替雷是被中外指南推荐可用于妊娠和哺乳期女性患者的一线疾病修饰治疗（DMT）药物 [17,18]；其在妊娠和哺乳期女性患者中应用，现有数据未观察到不良妊娠结局和胎儿/新生儿相关风险增加，可为育龄期患者提供坚固安全保障 [12-16]。
梯瓦大中华区总经理黄迪仁先生表示：「非常高兴见证醋酸格拉替雷注射液（固派松®）在中国的加速获批，这反映了中国在加速创新药品的审评审批，解决患者临床迫切需求的决心与行动。秉持着以患者为中心的理念，梯瓦将持续关注中国患者最迫切的临床需求，致力于将更多全球创新产品引入中国，造福中国患者，为『健康中国 2030』添『梯』加『瓦』。」
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Document Number：COP-CN-00002
Expected Duration of Use: 2 Years
* 仅供医学相关专业人士阅读或参考
参考文献
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