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辉瑞Xeljanz补充新药申请(sNDA)获FDA批准

来源:生物谷 2013-11-20 09:31

2013年11月20日讯 /生物谷BIOON/ --辉瑞(Pfizer)11月18日宣布,FDA已批准Xeljanz(tofacitinib citrate)补充新药申请(sNDA),将患者报告结果(Patient-Reported Outcomes,PRO)纳入药品标签。这些额外数据表明,接受Xeljanz治疗的患者,取得了基于患者自述健康相关预后方面的改善,包括:生命力(vitality)、角色心理状况(role emotional)、躯体机能(physical function)、肌体疼痛(bodily pain)、社会功能(social function)、心理健康(mental health)、 躯体角色(role physical)、一般健康状况(general health)。

Xeljanz为一种Janus激酶(JAK)抑制剂,是FDA批准的首个JAK抑制剂类口服类风湿性关节炎(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是一种日服2次(BID)的药物,于2012年11月获FDA批准,用于对氨甲喋呤(methotrexate,MTX)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。

在美国,Xeljanz可用作单药、或与甲氨蝶呤(MTX)或其他非生物类疾病修饰抗风湿药物(DMARDs)联合用药。此外,Xeljanz不应与生物类DMARDs或强效免疫抑制剂(如硫唑嘌呤、环孢素)联合用药。

英文原文:Pfizer Announces FDA Approval of Supplemental Application to Expand XELJANZ® (tofacitinib citrate) Labeling to Include Additional Patient-Reported Outcomes Data for Adults with Moderately to Severely Active Rheumatoid Arthritis

NEW YORK--(BUSINESS WIRE)--

Pfizer Inc. (PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib citrate) to include additional Patient-Reported Outcomes (PRO) data in the label. These additional data show improvement in patients receiving XELJANZ based on health-related outcome measures reported by patients, including vitality, role emotional, physical function, bodily pain, social function, mental health, role physical and general health, which are the eight domains of the Medical Outcomes Study Short-Form (36-Item) Health Survey (SF-36). XELJANZ 5 mg twice-daily (BID) was approved by the FDA in November 2012 for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX), and is the first approved RA treatment in the U.S. in a new class of medicines known as Janus kinase (JAK) inhibitors. In the U.S., XELJANZ may be used as monotherapy or in combination with MTX or other nonbiologic disease-modifying antirheumatic drugs (DMARDs). XELJANZ should not be used in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine.

“The patient-reported outcomes data show the impact that XELJANZ can have on the daily lives of patients with RA, based on physical, mental and emotional measures,” said Dr. Steven Romano, senior vice president and the head of the Medicines Development Group for Pfizer Specialty Care. “Following the FDA approval of XELJANZ in November 2012, we are pleased with the agency’s decision to approve this sNDA and add to the growing body of knowledge about XELJANZ as an additional treatment option for patients with RA.”

The approval of the PRO sNDA expands the U.S. label to include the results of health-related outcome measures from three Phase 3 studies in the XELJANZ clinical development program (ORAL Solo, Scan and Step, also identified as Studies I, IV and V, respectively, in the XELJANZ label), as assessed by SF-36. The expanded U.S. label now includes results showing that, at three months, patients receiving XELJANZ 5 mg BID or XELJANZ 10 mg BID in these studies demonstrated greater improvement from baseline compared to placebo in all eight domains of the SF-36, as well as the physical component summary (PCS) and mental component summary (MCS) scores. This expands upon data already included in the U.S. label at the time of FDA approval that showed XELJANZ improved physical function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI). The U.S. label specifies that 5 mg BID is the recommended dose. The 10 mg BID dose is not approved.

About XELJANZ

XELJANZ is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ is used to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work well.

It is not known if XELJANZ is safe and effective in people with Hepatitis B or C.
XELJANZ is not for people with severe liver problems.
It is not known if XELJANZ is safe and effective in children.

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