中文药名:富马酸二甲酯缓释胶囊

英文药名：TECFIDERA(dimethyl fumarate)

生产厂家：Biogen Idec公司制造

药品说明
美国初始批准：2013
适应证和用途
TECFIDERA适用为有复发型多发性硬化症患者的治疗
剂量和给药方法
（1）开始剂量：120 mg 1天2次，口服，共7天
（3）吞全和完整TECFIDERA胶囊。不要挤压，咀嚼，或洒胶囊剂内容无在食物上
（4）有或无食物服用TECFIDERA
剂型和规格
缓释胶囊：120 mg和240 mg
禁忌证
无
警告和注意事项
TECFIDERA可能致淋巴细胞减少。开始用TECFIDERA治疗前应得到最近全细胞计数. 建议每年全细胞计数，和当临床上指示时。在严重感染患者考虑不给治疗。
不良反应
最常见不良反应(发生率 ≥10%和≥2% 安慰剂)是脸红，腹痛，腹泻，和恶心

特殊人群中使用
●妊娠：根据动物数据，可能致胎儿危害

Biogen Idec's TECFIDERA(Dimethyl Fumarate) Approved in US as a First-Line Oral Treatment for Multiple Sclerosis
- Offers a Broad Spectrum of Patients with Relapsing Forms of MS an Effective and Convenient Treatment Option 
- Reduces Relapses and Disability Progression 
- Strengthens Biogen Idec's Portfolio of Innovative Treatments for People Living with MS
U.S. Food and Drug Administration (FDA) has approved TECFIDERA? (dimethyl fumarate), a new first-line oral treatment for people with relapsing forms of multiple sclerosis (MS). Biogen Idec will make this oral capsule available to people living with MS in the United States in the coming days.
TECFIDERA has been clinically proven to significantly reduce important measures of disease activity, including relapses and development of brain lesions, as well as to slow disability progression over time, while demonstrating a favorable safety and tolerability profile.
"With the FDA approval of TECFIDERA, we will offer the MS community a treatment with strong efficacy and a favorable safety profile in the convenience of a pill - a combination we believe will have a significant positive impact on the way people live with this chronic disease," said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. "Biogen Idec is committed to delivering innovative treatments and setting new standards for the next generation of medicines. We believe TECFIDERA will raise expectations for what people living with MS can achieve with their therapy."
The FDA approval of TECFIDERA is based on data from a robust clinical development program that included DEFINE and CONFIRM, two global Phase 3 studies that enrolled more than 2,600 patients. In the ongoing extension study, ENDORSE, some patients receiving TECFIDERA have been followed for more than four years.
In DEFINE, TECFIDERA, administered twice daily, significantly reduced the proportion of patients who relapsed by 49 percent (p<0.0001), the annualized relapse rate (ARR) by 53 percent (p<0.0001), and 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38 percent (p=0.0050) compared to placebo at two years. In CONFIRM, twice-daily TECFIDERA significantly reduced ARR by 44 percent (p<0.0001) and the proportion of patients who relapsed by 34 percent (p=0.0020) compared to placebo at two years. While not statistically significant, TECFIDERA showed a 21 percent reduction in 12-week confirmed disability progression in CONFIRM. Both studies also showed that TECFIDERA significantly reduced lesions in the brain compared to placebo, as measured by magnetic resonance imaging (MRI).
"In clinical trials, patients treated with dimethyl fumarate had less disease activity when compared to patients on placebo - whether they were in the early stages of MS or had more established disease," said Robert Fox, M.D., medical director of the Mellen Center for Multiple Sclerosis at Cleveland Clinic, lead investigator of the CONFIRM study, and a paid advisor for Biogen Idec for projects not related to TECFIDERA clinical development. "With the efficacy, safety and tolerability measures seen in CONFIRM, this drug provides physicians with an important additional treatment option for their patients across the MS spectrum."
The most common side effects associated with TECFIDERA are flushing and gastrointestinal (GI) events (i.e., diarrhea, nausea and abdominal pain). In clinical studies, flushing symptoms usually began soon after initiating treatment, were mostly mild to moderate, and usually improved or resolved over time. The incidence of GI events was higher early in the course of treatment (primarily in the first month) and decreased over time. Overall, clinical trial discontinuations due to flushing and GI events were low.
TECFIDERA may decrease lymphocyte counts in some patients. In clinical studies, mean lymphocyte counts decreased during the first year of treatment and then remained stable. The incidence of infections and serious infections was similar in TECFIDERA-treated patients and those on placebo. There were no opportunistic infections in TECFIDERA-treated patients. In patients with low lymphocyte counts, there was no increased incidence in serious infections. Patients taking TECFIDERA should have a complete blood count (CBC) before starting treatment to measure lymphocyte counts. A follow up CBC is recommended annually and at the discretion of the treating physician.
"We are pleased to see a new, needed treatment option available to people living with MS," said Dr. Timothy Coetzee, chief research officer at the National MS Society. "With the collaborative focus on MS research around the world, it is an exceptionally encouraging time for those who have been diagnosed with relapsing forms of MS."
TECFIDERA marks the fourth therapy Biogen Idec offers worldwide to people living with MS

ABOUT TECFIDERA™
TECFIDERA™ (dimethyl fumarate) is a new oral therapy recently approved in the United States for the treatment of relapsing forms of multiple sclerosis, including relapsing-remitting multiple sclerosis (RRMS), which is the most common form of the disease. TECFIDERA has been proven to significantly reduce important measures of disease activity, including relapses and development of brain lesions, as well as slow disability progression over time, while demonstrating a favorable safety and tolerability profile.

The most common adverse reactions for TECFIDERA were flushing, mostly mild to moderate in nature, and GI events (i.e., diarrhea, nausea, abdominal pain).  These events are most common at the start of therapy and usually decrease over time.
TECFIDERA may decrease lymphocyte counts. Before starting treatment with TECFIDERA, a recent CBC (i.e., within six months) should be available. A CBC is recommended annually and as clinically indicated.

TECFIDERA is also currently under review by regulatory authorities in the European Union, Australia, Canada and Switzerland.

FDA批准Biogen Idec的多发性硬化症候选药物TECFIDERA™ (DIMETHYL FUMARATE)
3月27日，美国食品药品管理局（FDA）批准百健艾迪旗下Tecfidera（富马酸二甲酯）胶囊用于治疗成人多发性硬化症(MS)复发。
多发性硬化症是一种慢性、炎症性中枢神经系统自身免疫性疾病，能够干扰大脑与身体其他部位之间的信号传递。多发性硬化症也是青壮年神经失能最常见的因素，并且女性的发病率要高于男性。对大多数多发性硬化症患者来说，日益恶化的功能性发作（复发）最初是发生在恢复期（缓解期）之后。随着时间的推移，恢复期可能会变得不完整，导致功能逐渐下降，残疾可能性增加。多发性硬化症患者经常会经历肌无力和协调及平衡困难过程。大多数患者首次出现多发性硬化症症状一般在20至40岁之间。
“现在还没有药物能够治愈多发性硬化症，所以能给患者提供多种治疗选择是非常重要的，” FDA药物评价和研究中心神经类产品部门主管Russell Katz医学博士如此说。“多发性硬化症能够损害人的运动、感觉及思维功能，并对人的生存质量有一种深远的影响。”
两项临床试验结果表明，服用Tecfidera患者与服用安慰剂患者相比，其多发性硬化症的复发变得更少。其中一项试验显示服用Tecfidera的患者其残疾的恶化程度要少于服安慰剂患者。
Tecfidera可能会减少患者的白细胞（淋巴细胞）数。淋巴细胞有助于抵抗感染，而低淋巴细胞计数可能增加感染风险，尽管临床试验过程中没有观察到Tecfidera服药患者有明显增加的感染风险。FDA建议给患者提供医疗保健的机构，在开始治疗之前及之后的每年对患者的白细胞计数进行评价。
临床试验中，接受Tecfidera治疗的患者最常见的副作用有脸红（脸热并发红）和胃部问题（恶心、呕吐、腹泻），主要出现在治疗的初期。这些副作用可能会随时间推移而降低。