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.
Pfizer Provides Update On Global Regulatory Approvals And Launches Of XELJANZ® (tofacitinib Citrate) For The Treatment Of Rheumatoid Arthritis
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