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辉瑞及武田在日本推出RA新药Xeljanz

来源:生物谷 2013-07-30 15:11

2013年7月30日讯 /生物谷BIOON/ --辉瑞(Pfizer)及武田(Takeda)今天联合宣布,在日本推出Xeljanz(tofacitinib citrate),该药于2013年3月25日获日本卫生劳动福利部(MHLW)批准,用于对现有疗法反应不足的类风湿性关节炎(RA)成人患者的治疗。此前双方已经在联合推广RA药物Enbrel(etanercept,依那西普)。

Xeljanz为一种Janus激酶(JAK)抑制剂,是日本获批的首个JAK抑制剂类口服RA药物。与生物制剂靶向于胞外细胞因子不同,Xeljanz靶向于JAK通路,该信号通路在RA炎症中发挥了关键作用。

Xeljanz可用于经至少一种疾病修饰抗风湿药物(DMARD,如氨甲喋呤)治疗后仍存在临床症状的患者。Xeljanz获批的剂量为5mg,每天2次。

Xeljanz用药,与增加的严重感染风险相关,包括机会性感染、结核、肿瘤、淋巴瘤。Xeljanz附带有一个有关这些风险的黑框警告。Xeljanz治疗也与胆固醇和肝酶的增加及血液计数的减少相关。

为了确保Xeljanz的安全和有效使用,辉瑞和武田将与日本风湿病学会合作,共同推进Xeljanz的正确使用。

此前,Xeljanz于2012年11月获FDA批准,用于对氨甲喋呤(methotrexate)治疗反应不足或不耐受的中度至重度活动性类风湿性关节炎(RA)成人患者的治疗,该药将与雅培(Abbott)重磅药物阿达木单抗(Humira)展开竞争。

阿达木单抗是一种可自我注射(Self-injectable)的生物治疗药物,Xeljanz则提供了口服的便利。

RA是一种自身免疫性疾病,由于人体免疫系统错误地攻击健康组织,导致关节及周围组织的炎症。(生物谷Bioon.com)

英文原文:NOVEL ORAL RHEUMATOID ARTHRITIS TREATMENT JAK INHIBITOR XELJANZ? LAUNCHED IN JAPAN

Promoting the Proper Use of New Treatment Option for Rheumatoid Arthritis

Pfizer Japan Inc. (Head Office: Shibuya-ku, Tokyo; “Pfizer”) and Takeda Pharmaceutical Company Limited (Head Office: Chuo-ku, Osaka; “Takeda”) announced today that the both parties have launched XELJANZ? (tofacitinib citrate). The medicine was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) on March 25, 2013 for the treatment of adults with rheumatoid arthritis (RA) who have had an inadequate response to existing therapies, and was listed in the NHI (National Health Insurance) Price List on May 24, 2013. Pfizer and Takeda have co-promoted the product as the both parties do for the RA drug Enbrel? (etanercept).

XELJANZ is the first approved oral RA treatment in a new class of medicines known as Janus kinase (JAK) inhibitor in Japan. Unlike biologic therapies that target cytokine outside the cell, the medicine targets the JAK pathways, which are signalling pathways inside the cell that play a role in the inflammation involved in RA.

XELJANZ may be used in patients in whom clinical symptoms due to the disease remain even after appropriate treatment with at least one other disease-modifying antirheumatic drug (DMARD), such as methotrexate. The approved dose of XELJANZ is 5 mg twice daily.

In order to ensure that XELJANZ is used safely and effectively, Pfizer and Takeda are, with the cooperation of the Japan College of Rheumatology, working to promote proper use of the product through the implementation of all cases surveillance in accordance with the College’s “Guidelines for Using Tofacitinib in All Cases Surveillance.” In the Guidelines, XELJANZ is recommended for patients whose RA cannot be controlled even after more than three months of continuous treatment with over 8mg per week of methotrexate. Through the all cases surveillance, 4,000 patients with XELJANZ over an observation period of three years, additional information on XELJANZ’s safety and efficacy is being collected and analyzed. Another group consisting of 2,000 patients starting RA medical treatment, but not with XELJANZ, is included in the surveillance so that a comparative study measuring the occurrence of malignant tumors and serious infections can be carried out.

“Rheumatoid arthritis is a serious disease causing physical impediments. Some patients cannot achieve adequate results with existing treatments and I have high hopes that the emergence of this new, highly convenient product will lead to better patient quality-of-life,” said Professor Yoshiya Tanaka, First Department of Internal Medicine, University of Occupational and Environmental Health, Japan. “XELJANZ, which has a new mechanism of action, has been recognized for its safety and efficacy through domestic clinical trials, but it is important to promote the proper use of the medicine and to continue accumulating clinical evidence from the field.”

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