——为中国患者供给全新医治选择

梯瓦中国（Teva）公布，中国国度药品监视治理局（NMPA）在近日正式核准了"醋酸格拉替雷打针液"。该药品注册商标为固派松®、Copaxone®，以下简称固派松®。该药品合用在医治复发型多发性硬化（MS）成人患者，包罗临床孤立综合征、复发减缓型多发性硬化和勾当性继发进展型多发性硬化。此次获批规格（20mg/ml和40mg/ml）均取得美国食物药品监视治理局（FDA）核准，此中，40mg/ml下降了每周给药频次，提高了患者允从性和便当性。

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，常见临床表示为频频爆发的目力降落、复视、肢体感受障碍、肢体活动障碍、共济掉调、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），在中国的病发率为每一年0.235/10万人[1]，是除创伤外年青成人永远残疾的最多见病因[2]。

经典药物，统筹疗效与持久平安性

固派松®是由4种自然氨基酸L-谷氨酸、L-丙氨酸、L-酪氨酸和L-赖氨酸构成的合成多肽的醋酸盐。作为医治复发型多发性硬化成人患者的一线疾病批改医治药物，固派松®已在全球50多个国度获批，临床利用跨越27年，疗效切当，具有杰出的持久平安性和耐受性。

近30年的临床研究数据证实[3-15]，固派松®可显著下降复发率和疾病勾当性，改良患者残疾进展和脑萎缩，下降临床孤立综合征转归为多发性硬化的风险，同时还可改良疲惫、认知功能和痉挛等症状。另外，固派松®持久平安性杰出，无较着时候依靠性的不良反映，非非凡环境不必监测。

聚焦育龄期患者，知足火急临床需求

据统计，多发性硬化多发在青丁壮，育龄期女性患者占比力高。有研究显示，部门女性患者因生育打算致疾病润色医治严重推延，使残疾进展风险增添。对有怀孕打算、呈现不测怀孕或处在哺乳期的女性患者，现有医治多采取停药处置，部门疾病润色医治药物乃至需要进行快速洗脱，可见育龄期患者的火急临床需求并未被知足。

固派松®是今朝独一一款被中外指南保举可用在怀胎和哺乳期女性患者的一线疾病润色医治（DMT）药物。其在怀胎和哺乳期女性患者中利用，未不雅察到不良怀胎终局和胎儿/新生儿相干风险增添，可为育龄期患者供给坚忍平安保障。

梯瓦年夜中华区总司理黄迪仁师长教师暗示："很是兴奋见证固派松®在中国的加快获批，这反应了中国在加快立异药品的审评审批，解决患者临床火急需求的决心与步履。秉承着以患者为中间的理念，梯瓦将延续存眷中国患者最火急的临床需求，致力在将更多全球立异产物引入中国，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 scleros开云appis: 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 Japanese 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.