梯瓦多發(fā)性硬化藥物固派松? 在華獲批
——為中國(guó)患者提供全新治療選擇
梯瓦中國(guó)（Teva）宣布，中國(guó)國(guó)家藥品監(jiān)督管理局（NMPA）于近日正式批準(zhǔn)了"醋酸格拉替雷注射液"。該藥品注冊(cè)商標(biāo)為固派松?、Copaxone?，以下簡(jiǎn)稱固派松?。該藥品適用于治療復(fù)發(fā)型多發(fā)性硬化（MS）成人患者，包括臨床孤立綜合征、復(fù)發(fā)緩解型多發(fā)性硬化和活動(dòng)性繼發(fā)進(jìn)展型多發(fā)性硬化。此次獲批規(guī)格（20mg/ml和40mg/ml）均獲得美國(guó)食品藥品監(jiān)督管理局（FDA）批準(zhǔn)，其中，40mg/ml降低了每周給藥頻次，提高了患者依從性和便利性。
多發(fā)性硬化是一種免疫介導(dǎo)的中樞神經(jīng)系統(tǒng)炎性脫髓鞘疾病，常見臨床表現(xiàn)為反復(fù)發(fā)作的視力下降、復(fù)視、肢體感覺障礙、肢體運(yùn)動(dòng)障礙、共濟(jì)失調(diào)、膀胱或直腸功能障礙等。據(jù)統(tǒng)計(jì)，全球約280萬多發(fā)性硬化患者（2020年），在中國(guó)的發(fā)病率為每年0.235/10萬人[1]，是除創(chuàng)傷外年輕成人永久殘疾的最常見病因[2]。
經(jīng)典藥物，兼顧療效與長(zhǎng)期安全性
固派松?是由4種天然氨基酸L-谷氨酸、L-丙氨酸、L-酪氨酸和L-賴氨酸組成的合成多肽的醋酸鹽。作為治療復(fù)發(fā)型多發(fā)性硬化成人患者的一線疾病修正治療藥物，固派松?已在全球50多個(gè)國(guó)家獲批，臨床應(yīng)用超過27年，療效確切，具有良好的長(zhǎng)期安全性和耐受性。
近30年的臨床研究數(shù)據(jù)證實(shí)[3-15]，固派松?可顯著降低復(fù)發(fā)率和疾病活動(dòng)性，改善患者殘疾進(jìn)展和腦萎縮，降低臨床孤立綜合征轉(zhuǎn)歸為多發(fā)性硬化的風(fēng)險(xiǎn)，同時(shí)還可改善疲勞、認(rèn)知功能和痙攣等癥狀。此外，固派松?長(zhǎng)期安全性良好，無明顯時(shí)間依賴性的不良反應(yīng)，非特殊情況無須監(jiān)測(cè)。
聚焦育齡期患者，滿足迫切臨床需求
據(jù)統(tǒng)計(jì)，多發(fā)性硬化多發(fā)于青壯年，育齡期女性患者占比較高。有研究顯示，部分女性患者因生育計(jì)劃致疾病修飾治療嚴(yán)重推遲，使殘疾進(jìn)展風(fēng)險(xiǎn)增加。對(duì)于有懷孕計(jì)劃、出現(xiàn)意外懷孕或處于哺乳期的女性患者，現(xiàn)有治療多采用停藥處理，部分疾病修飾治療藥物甚至需要進(jìn)行快速洗脫，可見育齡期患者的迫切臨床需求并未被滿足。
固派松?是目前唯一一款被中外指南推薦可用于妊娠和哺乳期女性患者的一線疾病修飾治療（DMT）藥物。其在妊娠和哺乳期女性患者中應(yīng)用，未觀察到不良妊娠結(jié)局和胎兒/新生兒相關(guān)風(fēng)險(xiǎn)增加，可為育齡期患者提供堅(jiān)固安全保障。
梯瓦大中華區(qū)總經(jīng)理黃迪仁先生表示："非常高興見證固派松?在中國(guó)的加速獲批，這反映了中國(guó)在加速創(chuàng)新藥品的審評(píng)審批，解決患者臨床迫切需求的決心與行動(dòng)。秉持著以患者為中心的理念，梯瓦將持續(xù)關(guān)注中國(guó)患者最迫切的臨床需求，致力于將更多全球創(chuàng)新產(chǎn)品引入中國(guó)，造福中國(guó)患者，為‘健康中國(guó)2030'添‘梯'加‘瓦'。"
參考文獻(xiàn)
[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 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.
