XeljanzTreatment for Rheumatoid Arthritis
Update: Xeljanz (tofacitinib) Now FDA Approved - November 6, 2012
FDA Accepts Tofacitinib NDA for Review
Pfizer Announces FDA Acceptance for Review of New Drug Application for Tofacitinib for Adult Patients with Moderately to Severely Active Rheumatoid Arthritis
NEW YORK--(BUSINESS WIRE)--Dec 20, 2011 - Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tofacitinib (development code CP-690,550), an investigational novel, oral JAK inhibitor being studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in August 2012 for the NDA. Pfizer has also submitted an application for this indication for tofacitinib to regulatory authorities in Japan.
As disclosed in November, an application for tofacitinib for the treatment of adult patients with moderate-to-severe active RA is being reviewed by the European Medicines Agency.
“Pfizer is pleased to have achieved this regulatory milestone, which reflects our commitment to advancing treatments for inflammatory conditions, and constitutes a significant step toward bringing tofacitinib to RA patients who are in need of additional therapeutic options,” said Geno Germano, president and general manager, Specialty Care and Oncology, Pfizer Inc. “We are proud of the comprehensive Phase 3 clinical program that we have completed and believe that, if approved by the FDA, tofacitinib has the potential to improve the lives of people with RA.”
About Rheumatoid Arthritis
Rheumatoid arthritis is a chronic inflammatory autoimmune disease that typically affects the hands and feet, although any joint lined by a synovial membrane may be affected. RA affects approximately 1.3 million Americansi and one percent of the population worldwide.ii
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DISCLOSURE NOTICE: The information contained in this release is as of December 20, 2011. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information that involves substantial risks and uncertainties about a product in development, tofacitinib, including its potential benefits as a treatment for moderate-to-severe active RA, that is under review by regulatory authorities in the U.S., EU and Japan. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by those regulatory authorities regarding whether and when to approve drug applications that have been filed for tofacitinib for moderate-to-severe active RA, as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and in its reports on Form 10-Q and Form 8-K.
i Arthritis Today. “What is Rheumatoid Arthritis.” Accessed 24 February 2011. Available at: http://www.arthritistoday.org/conditions/rheumatoid-arthritis/all-about-ra/what-is-ra.php.
ii Lee DM, Weinblatt ME. Rheumatoid arthritis. Lancet. 2001; 358:903-911.
Posted: December 2011
- Pfizer Announces FDA Approval of Xeljanz XR (tofacitinib citrate), the First and Only Once-Daily Oral JAK Inhibitor Treatment for Rheumatoid Arthritis - February 24, 2016
- FDA Approves Xeljanz for Rheumatoid Arthritis - November 6, 2012
- U.S. Food And Drug Administration Extends Action Date For Tofacitinib New Drug Application By Three Months - August 21, 2012
- FDA Arthritis Advisory Committee Recommends Approval of Tofacitinib for Adult Patients with Moderately to Severely Active Rheumatoid Arthritis - May 9, 2012