辉瑞Xelganz获多国批准用于类风湿性关节炎（RA）

辉瑞（Pfizer）今日宣布，Xelganz（tofacitinib citrate）获多个国家批准，用于对现有疗法反应不足的类风湿性关节炎（RA）患者的治疗。其中，瑞士是欧洲首个获批准入的国家，瑞士医药管理局（Swissmedic）批准以5mg和10mg剂量Xelganz每日2次（BID）作为单药或与一种疾病修饰非生物抗风湿剂（DMARD，包括甲氨蝶呤MTX）用于对现有疗法（MTX）反应不足或不耐受MTX治疗的中度至重度活动性类风湿性关节炎（RA）成人患者的治疗。

tofacitinib 5mg剂量BID已获阿根廷、科威特、阿拉伯联合酋长国批准，tofacitinib 5mg和10mg剂量BID已获俄罗斯批准。

此前，tofacitinib已获美国及日本批准，用于中度至重度活动性RA。该药是首个获批的名为Janus激酶（JAK）抑制剂的新一类RA药物，具有口服给药的优势，不像雅培（Abbott）公司抗肿瘤坏死因子（anti-TNF）药物-阿达木单抗（Humira），该药为注射制剂。

英文原文：Pfizer Provides Update on Global Regulatory Approvals and Launches of XELJANZ? (tofacitinib citrate) for the Treatment of Rheumatoid Arthritis

Monday, July 15, 2013 - 6:00am EDT

NEW YORK, N.Y., July 15 - Pfizer Inc. (NYSE: PFE) announced today that tofacitinib has been approved for the treatment of rheumatoid arthritis (RA) in patients who had an inadequate response to existing therapies in several additional countries around the world, including Switzerland, which is the first European country to receive approval. Swissmedic, the Swiss agency for therapeutic products, approved tofacitinib 5 and 10 mg twice-daily (BID) as monotherapy or in combination with a disease modifying non-biologic antirheumatic agent (DMARD), including methotrexate (MTX), in adult patients with moderate-to-severe active RA who have had an inadequate response or intolerance to MTX.  Tofacitinib 5 mg BID has also been approved in Argentina, Kuwait and the United Arab Emirates, and tofacitinib 5 mg and 10 mg BID has been approved in Russia. The brand name for tofacitinib in the approved markets will be XELJANZ, except for Russia, where the brand name will be Jaquinus?.

As previously announced, XELJANZ 5 mg BID is also approved in the United States and Japan for the treatment of moderate-to-severe active RA. XELJANZ was launched in the United States in November 2012, and XELJANZ is expected to be commercially available in Japan this month following approval by the Japanese Ministry of Health, Labor and Welfare (MHLW) in March 2013. XELJANZ will be co-promoted in Japan by Pfizer and Takeda Pharmaceutical Company Limited. Initially, XELJANZ will be made available in Japan to medical institutions participating in an all-patient surveillance program, designed by Pfizer in collaboration with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and the Japan College of Rheumatology.

“More than 23 million people worldwide are living with rheumatoid arthritis and there remains an unmet need for additional treatments, with up to one-third of RA patients not adequately responding and about half who stop responding to any particular DMARD within five years,” said Geno Germano, president and general manager, Specialty Care and Oncology, Pfizer. “XELJANZ has a novel mechanism of action for the treatment of moderate-to-severe RA. With these approvals, we believe XELJANZ has the potential to change the way rheumatologists treat this chronic, and potentially disabling, disease, and we are proud to offer patients and physicians an additional treatment option.”

Regulatory applications for XELJANZ for the treatment of moderate-to-severe active RA remain under review in more than 30 additional countries. In Europe, Pfizer is seeking a re-examination of the Committee for Medicinal Products for Human Use (CHMP) negative opinion that was announced in April, and the company is currently working with the CHMP on the next steps in the process.

XELJANZ is the first approved RA treatment in a new class of medicines known as Janus kinase (JAK) inhibitors. The recent marketing authorizations for XELJANZ were based on data from the comprehensive, global, multi-study clinical development program for XELJANZ, which included approximately 5,000 patients in more than 40 countries, resulting in 7,000 patient-years of experience at the time of regulatory submission.

(责任编辑：lili.zhao)