Pfizer Inc. (NYSE:PFE) announced today that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for XELJANZ® (tofacitinib citrate) 5 mg tablets twice daily for the treatment of patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX). The EMA will now initiate its review of the XELJANZ MAA.
This application provides additional information to the original MAA submission, including data from the Phase 3 ORAL (Oral Rheumatoid Arthritis Phase 3 TriaLs) global development program in RA. This program consisted of six completed clinical trials, in addition to two open-label long-term extension (LTE) studies, one of which is still ongoing. To date, the ORAL development program has accumulated more than 19,400 patient-years of drug exposure having been studied in more than 6,100 patients including follow-up observations of up to eight years in the LTE study.1
“We are committed to making XELJANZ available to RA patients in the EU. The up to eight years of data that we have accumulated demonstrate our commitment to understanding the efficacy and safety of XELJANZ in patients living with RA,” said Michael Corbo, Category Development Lead, Inflammation & Immunology, Pfizer Global Innovative Pharmaceuticals Business. “We look forward to working together with the EMA on its review.”
XELJANZ is the only oral Janus kinase (JAK) inhibitor approved in more than 45 countries around the world for the treatment of moderate to severe RA. Since XELJANZ was first approved in the U.S. in 2012, it has been prescribed to more than 50,000 patients worldwide.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic, inflammatory autoimmune disease that causes a range of symptoms, including pain and swelling in the joints,2,3 particularly those in the hands, feet and knees.3 Although the exact cause of RA is unknown,3 it is considered to be an autoimmune disease, because the immune system in people with RA mistakes the body’s healthy tissues for a threat and attacks them.3 Some people are at increased risk of developing RA, including people with a family history of RA, smokers and women.4 Three times as many women are affected by RA compared to men.3 RA affects approximately 23.7 million people worldwide5 and 1.6 million people in the United States.6,7 It can develop at any time during adulthood, but it usually occurs between 40 and 70 years of age.3
About XELJANZ (tofacitinib citrate)
XELJANZ® is a prescription medicine called a Janus kinase (JAK) inhibitor.
As the developer of XELJANZ, Pfizer is a leader in JAK innovation. XELJANZ does not require injections or infusions. XELJANZ can be taken with or without methotrexate.
XELJANZ is approved in more than 45 countries around the world for the treatment of moderate to severe RA as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs (DMARDs).
Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of XELJANZ through a robust clinical development program.
About XELJANZ XR (tofacitinib citrate) extended-release
Pfizer has also developed an extended-release formulation, XELJANZ XR 11 mg, the first and only once-daily oral JAK inhibitor for the treatment of moderate to severe RA, approved in the United States.
XELJANZ/XELJANZ XR U.S. Label Information
XELJANZ/XELJANZ XR is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ/XELJANZ XR is used to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work well. XELJANZ/XELJANZ XR may be used as a single agent or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (DMARDs). Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine is not recommended.
Important Safety Information
It is not known if XELJANZ/XELJANZ XR will harm an unborn baby. To monitor the outcomes of pregnant women exposed to XELJANZ/XELJANZ XR, a registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972.
Please click the direct link to the full prescribing information for XELJANZ/XELJANZ XR, including boxed warning and Medication Guide: http://labeling.pfizer.com/ShowLabeling.aspx?id=959.
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DISCLOSURE NOTICE: The information contained in this release is as of March 23, 2016. 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 about a potential indication in Europe for XELJANZ® (tofacitinib citrate) 5 mg tablets twice daily for the treatment of patients with moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate (the “potential indication”), including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; whether and when the European Medicines Agency may approve the Marketing Authorization Application for the potential indication and whether and when regulatory authorities in any other jurisdictions where applications are pending or may be submitted for the potential indication may approve any such applications, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of XELJANZ and XELJANZ XR; 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, 2015 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
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1 CII_Adhoc_944_P123LTE_21AUG2015. Tofacitinib Protocol P123LTE. Table 126.96.36.199.A
2 Lee DM, Weinblatt ME. Rheumatoid arthritis. Lancet. 2001; 358:903-911.
3 Medline Plus, “Rheumatoid Arthritis” Accessed 11 October 2011. Available athttp://www.nlm.nih.gov/medlineplus/ency/article/000431.htm.
4 Mayo Clinic, “Rheumatoid Arthritis.” Accessed 14 September 2011. Available athttp://www.mayoclinic.com/health/rheumatoid-arthritis/DS00020/DSECTION=risk-factors.
5 Annals of Rheumatic Diseases, “The global burden of rheumatoid arthritis: estimates from the Global Burden of Disease 2010 study.” Accessed 14 July 2015. Available at http://ard.bmj.com/content/early/2014/02/18/annrheumdis-2013-204627.
6 Sacks, J., Lou, Y., Helmick, C. Prevalence of Specific Types of Arthritis and Other Rheumatic Conditions in the Ambulatory Health Care System in the United States 2001-2005. Arthritis Care and Research. 2010. 62(4): 460- 464.
7 Howden, L., Meyer, J., 2010 U.S. Census Bureau results --- U.S. Census Bureau, 2010 Census Summary File 1.