——为中国患者提供全新治疗选择

       2023年6月28日，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"。该药品注册商标为固派松®、Copaxone®，以下简称固派松®。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（20mg/ml和40mg/ml）均获得美国食品药品监督管理局（FDA）批准，其中， 40mg/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），在中国的发病率为每年0.235/10万人[1]，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

       固派松®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，固派松®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 [3-15] ，固派松®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，固派松®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。

       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。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。

       固派松®是目前唯一一款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。其在妊娠和哺乳期女性患者中应用，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。

       梯瓦大中华区总经理黄迪仁先生表示："非常高兴见证固派松® 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'。"

       参考文献

       [1] Incidence of multiple sclerosis in China: A nationwide hospital-based study. The Lancet Regional Health 2020, 1(10010). https://doi.org/10.1016/j.lanwpc.2020.100010

       [2] Tian D C, Zhang C, Yuan M, et al. Incidence of multiple sclerosis in China: a nationwide hospital-based study[J]. The Lancet Regional Health-Western Pacific, 2020, 1: 100010.

       [3] Bornstein MB, et al. A pilot trial of Cop 1 in exacerbating-remitting multiple sclerosis. N Engl J Med. 1987 Aug 13;317(7):408-14.

       [4] Johnson KP, et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial. The Copolymer 1 Multiple Sclerosis Study Group. Neurology. 1995 Jul;45(7):1268-76.

       [5] Comi G, et al. European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging--measured disease activity and burden in patients with relapsing multiple sclerosis. European/Canadian Glatiramer Acetate Study Group. Ann Neurol. 2001 Mar;49(3):290-7.

       [6] Khan O, et al; GALA Study Group. Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis. Ann Neurol. 2013 Jun;73(6):705-13.

       [7] Comi G, et al; PreCISe study group. Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Oct 31;374(9700):1503-11.

       [8] Yamamura T, et al. Once-daily glatiramer acetate decreases magnetic resonance imaging disease activity in J apanese patients with relapsing-remitting multiple sclerosis. Clin Exp Neuroimmunol. 2017 May;8 (2):129-137.

       [9] Ford CC, et al. Early versus delayed treatment with glatiramer acetate: Analysis of up to 27®years of continuous follow-up in a US open-label extension study. Mult Scler. 2022 Oct;28(11):1729-1743.

       [10] Rieckmann P,et al. Long-term efficacy and safety of three times weekly dosing regimen of glatiramer acetate in relapsing multiple sclerosis patients: Seven-year results of the Glatiramer Acetate Low-frequency Administration (GALA) open-label extension study. Mult Scler J Exp Transl Clin. 2021 Dec 13;7(4):20552173211061550.

       [11] Khan O, et al. Efficacy and safety of a three-times-weekly dosing regimen of glatiramer acetate in relapsing-remitting multiple sclerosis patients: 3-year results of the Glatiramer Acetate Low-Frequency Administration open-label extension study. Mult Scler. 2017 May;23(6):818-829.

       [12] Sandberg-Wollheim M, et al. Pregnancy Outcomes from the Branded Glatiramer Acetate Pregnancy Database. Int J MS Care. 2018 Jan-Feb;20(1):9-14.

       [13] Kaplan S, et al Outcomes Following Maternal Exposure to Glatiramer Acetate During Pregnancy and Breastfeeding. Drug Saf. 2022 Apr;45(4):345-357.

       [14] Herbstritt S, et al Glatiramer acetate during early pregnancy: A prospective cohort study. Mult Scler. 2016 May;22(6):810-6.

       [15] Ciplea AI, et al. Eighteen-month safety analysis of offspring breastfed by mothers receiving glatiramer acetate therapy for relapsing multiple sclerosis - COBRA study. Mult Scler. 2022 Sep;28(10):1641-1650.

       [16] Cinar BP, et al. Cognitive dysfunction in patients with multiple sclerosis treated with first-line disease-modifying therapy: a multi-center, controlled study using the BICAMS battery. Neurol Sci. 2017 Feb;38(2):337-342.