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Pfizer Inc. (PFE) Announces FDA Approval To Include Radiographic Data On Reduction Of Progression Of Structural Joint Damage For Adults With Moderately To Severely Active Rheumatoid Arthritis In Labeling For XELJANZ® (Tofacitinib Citrate)


2/20/2014 10:35:56 AM

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NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) to update the current label of XELJANZ® (tofacitinib citrate) 5 mg tablets to include radiographic data from two Phase 3 studies, ORAL Scan (A3921044) and ORAL Start (A3921069). “XELJANZ is the first oral JAK inhibitor for moderately to severely active rheumatoid arthritis. The reduction of radiographic progression seen in ORAL Scan and ORAL Start represents a clinically meaningful outcome for patients,” said Dr. Steven Romano, Global Medicines Development Lead for the Pfizer Global Innovative Pharmaceutical business.

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