2013年9月1日讯 --赛诺菲（Sanofi）及旗下健赞（Genzyme）8月30日宣布，口服多发性硬化症药物Aubagio（teriflunomide，特立氟胺）已获得欧盟委员会（EC）的批准，作为一种新的日服一次的药物，用于复发型多发性硬化症（multiple sclerosis，MS）成人患者的治疗。
Aubagio的获批，是基于III期TEMSO和TOWER研究的数据，数据表明，在为期2年的治疗中，与安慰剂相比，Aubagio显着降低了MS的年复发率，同时延缓了残疾进展。
此外，有研究表明，Aubagio的效果低于一些竞争对手的MS药物，如默沙东（Merck & Co）的Rebif，但Aubagio的优势在于口服，同时副作用更为温和。分析师称，该药可能会受到新诊患者的青睐。大约有35%~40%的多发性硬化症患者宁愿不采取任何药物治疗，也不愿经历不必要的副作用。Rebif是一种常用的注射类MS药物。
多发性硬化症，目前无可治愈的药物，影响着全球约210万人，欧洲约有60万患者，这是一种慢性、往往致残性疾病，攻击中枢神经系统，可导致肢体麻木、瘫痪、视力丧失。
临床试验中，与Aubagio服药相关的最常见副作用包括丙氨酸氨基转移酶水平的升高，表明该药可能损害肝脏，其他的副作用包括脱发、腹泻、感冒、恶心、皮肤麻木。
目前，Aubagio已获美国、澳大利亚、阿根廷、智利、韩国批准。
EU approves Sanofi multiple sclerosis drug Aubagio
Paris, France – August 30, 2013 – Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced today that the European Commission has granted marketing authorization for Aubagio? (teriflunomide) 14 mg, a once-daily, oral therapy indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS).
“The fact that Aubagio 14 mg has demonstrated a positive effect on disability progression in two phase III clinical studies underscores its importance as a new treatment option for relapsing remitting MS patients,"said Professor Ludwig Kappos, MD, Chair of Neurology, University Hospital, Basel, Switzerland. "As a new once-daily, oral treatment option with well-characterized safety and tolerability, Aubagio could be an attractive option for patients dissatisfied with traditional injectable therapies."
The EU approval of Aubagio was based on data from the Phase III TEMSO (TEriflunomide Multiple Sclerosis Oral) and TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis) trials. In these trials, Aubagio significantly reduced the annualized relapse rate and the time to disability progression at two years versus placebo.
“Aubagio’s efficacy, safety and convenient dosing may provide an attractive treatment option for patients,”said Genzyme CEO and President, David Meeker, M.D. “Today’s approval of Aubagio is another step forward for Genzyme as we work to develop important new treatments that can address the perse needs of the MS community.”
Multiple sclerosis is estimated to affect more than 2.1 million people globally. There are approximately 630,000 people affected by MS in Europe.
The development of Aubagio reflects more than a decade of work by the Sanofi R&D organization.
Aubagio is approved to treat relapsing MS in the United States, Australia, Argentina, Chile and South Korea, and is under review by additional regulatory agencies.
About Aubagio (teriflunomide)
Aubagio is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Aubagio is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS). Aubagio is supported by one of the largest clinical programs of any MS therapy, with more than 5,000 trial participants in 36 countries. Some patients in extension trials have been treated for up to 10 years.
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