赛诺菲多发性硬化症药物Aubagio获加拿大批准

赛诺菲（Sanofi）及旗下健赞（Genzyme）宣布，口服多发性硬化症药物Aubagio（teriflunomide，特立氟胺）已获加拿大卫生部批准，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，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。

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。

今年9月，Aubagio获欧盟委员会（EC）批准。此前，Aubagio也已获美国、澳大利亚、阿根廷、智利、韩国批准。

多发性硬化症，目前无可治愈的药物，影响着全球约210万人。在加拿大，约有10万MS患者，每天新增3例新诊患者，在全球范围内，加拿大MS患病率最高。由于大多数人被诊断时是在其20-30岁，因此，在加拿大，MS是影响年轻人的最常见神经系统疾病。

英文原文：Health Canada Approves Genzyme's AUBAGIO? (teriflunomide), a Once-Daily, Oral Treatment for Relapsing Remitting Multiple Sclerosis

MISSISSAUGA, ON, Nov. 20, 2013 /CNW/ - Genzyme, a Sanofi company, announced today that Health Canada has approved AUBAGIO? (teriflunomide) 14 mg as monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.

"There are many patients who simply cannot tolerate injections and have had no simple, effective, once daily oral medication until now," said Dr. Mark Freedman, Director, Multiple Sclerosis Research Unit and Professor of Neurology and Senior Scientist at the University of Ottawa and Ottawa Hospital Research Institute. "As a new oral treatment option, AUBAGIO is an important advancement for the MS community and may help improve quality of life for people living with this debilitating disease."

The Health Canada approval was based on efficacy data from two Phase III clinical trials - TEMSO (TEriflunomide Multiple Sclerosis Oral) and TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis). In the TEMSO trial, AUBAGIO 14 mg significantly reduced the annualized relapse rate (p=0.0005) and the time to disability progression (p=0.0279) at two years versus placebo in patients with RRMS. In the TOWER trial, AUBAGIO 14 mg significantly reduced the annualized relapse rate (p=0.0001) and the time to disability progression sustained for 12 weeks (p = 0.0442) was statistically significantly reduced versus placebo in patients with RRMS.

"MS impacts each person differently, which is why increased options are important when it comes to making personal treatment decisions. The more treatment options that are available the more choices Canadians living with MS have to potentially improve their overall quality of life," said Dr. Karen Lee, Vice-President, Research, Multiple Sclerosis Society of Canada. "As we learn more about MS and develop therapies that reduce the frequency and severity of relapses in relapsing-remitting MS, we hope that we'll also uncover treatments for people whose disease is steadily progressing."

New positive data from the TOPIC study of AUBAGIO was presented at the 29th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark. The double-blind, multi-centre trial enrolled 618 patients who had experienced a first acute or sub-acute, well-defined neurological event consistent with demyelination as well as onset of MS symptoms within 90 days of randomization, and MRI scan showing two or more lesions characteristic of MS. The two-year study was designed to assess whether early initiation of AUBAGIO in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack.

The TOPIC study found AUBAGIO 14 mg significantly reduced the risk of a new clinical relapse over the two-year study period. There was a 35 per cent reduction among patients who received AUBAGIO 14 mg compared to placebo (p=0.0374).

"We are very excited that AUBAGIO will be available for Canadians living with RRMS," said Peter Brenders, General Manager, Genzyme Canada. "Health Canada's approval of our first MS therapy represents an important milestone for us, and we are proud of our commitment to long-term leadership and partnership with the MS community."

As part of its commitment to MS patients, Genzyme has developed the MS One to One? program. MS One to One will offer comprehensive support services, including: reimbursement navigation and other financial assistance, patient education and compliance services, medication delivery, and facilitation of the accelerated elimination procedure. Staffed by dedicated MS nurses and highly trained representatives, MS One to One can provide support for individuals living with MS, their health care providers, family and loved ones. Please consult your healthcare provider for more information.

In MS clinical studies with AUBAGIO, the incidence of serious adverse events were similar among AUBAGIO and placebo-treated patients. The most common adverse events associated with AUBAGIO in MS patients included alopecia, diarrhea, increased ALT levels, headache and nausea.

The AUBAGIO label includes a boxed warning citing the risk of hepatotoxicity and teratogenicity (based on animal data).

The labeling for AUBAGIO was also informed by the estimated 2.1 million years of patient exposure globally since the launch of leflunomide, which is indicated in the US for the treatment of rheumatoid arthritis. Teriflunomide is the principal active metabolite of leflunomide. Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide.

AUBAGIO is also approved in the United States, Europe, Australia, Argentina, Chile, South Korea and Mexico for the treatment of relapsing forms of MS. Marketing applications for AUBAGIO are also under review by additional regulatory authorities globally.

About MS in Canada

With 100,000 Canadians living with MS and three people newly diagnosed every day, Canada has one of the highest rates in the world. As most people are diagnosed with relapsing MS in their 20s and 30s, MS is the most common neurological disease affecting young adults in Canada.

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.