- Approval Provides People Living with RA in the European Union with a New Oral Treatment Option
Pfizer Inc. (NYSE:PFE) announced today that the European Commission (EC) has approved XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) oral tablets in combination with methotrexate (MTX) for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). XELJANZ can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. XELJANZ belongs to a new class of therapies called Janus kinase (JAK) inhibitors.
“With the approval of tofacitinib, rheumatologists and patients in the EU now have an additional treatment option for the management of rheumatoid arthritis that can be taken with or without methotrexate,” said Ronald van Vollenhoven, Professor of Rheumatology and Director of the Amsterdam Rheumatology and Immunology Center ARC. “This is an important advancement for the rheumatology community as up to one-third of people with rheumatoid arthritis may not achieve a response with current treatments and a number of patients may not sustain a response.”
The EC approval is based on a submission package that included results from the Phase 3 Oral Rheumatoid Arthritis triaLs (ORAL) global development program and real world data. Results from this clinical trial program conducted in a diverse RA patient population demonstrated the efficacy and safety profile of XELJANZ both with and without MTX for the treatment of moderate to severe RA. The XELJANZ development program includes more than eight years of safety data from the long-term extension studies representing over 21,100 patient-years of drug exposure to date.
“With a heritage of more than 60 years of providing rheumatoid arthritis treatment options, Pfizer has been a leader in helping to improve the lives of people with inflammatory conditions,” said Angela Lukin, Regional President, Inflammation & Immunology, Pfizer Innovative Health. “The approval of XELJANZ in Europe demonstrates Pfizer’s ongoing commitment to developing medicines that address unmet needs for people living with chronic conditions like rheumatoid arthritis.”
Pfizer is working with the appropriate authorities in European Union (EU) countries to support reimbursement and availability of XELJANZ with the goal of helping to ensure people who may benefit from XELJANZ have access to it. With the approval in the EU, XELJANZ is now approved for use in more than 80 countries worldwide.
About Rheumatoid Arthritis (RA)
RA is a chronic, inflammatory autoimmune disease that causes a range of symptoms, including pain and swelling in the joints, particularly those in the hands, feet and knees. Although the exact cause of RA is unknown, 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. Some people are at increased risk for developing RA, including people with a family history of RA, smokers and women. Three times as many women are affected by RA compared to men. RA affects approximately 17.6 million people worldwide and more than 2.9 million people in Europe. It can develop at any time during adulthood, but it usually occurs between 40 and 70 years of age.
About XELJANZ (tofacitinib citrate)
XELJANZ is a JAK inhibitor, a new class of drugs for the treatment of RA in the EU. JAK inhibitors act on the JAK pathway by working inside the cell to disrupt a signaling pathway believed to play a role in the inflammation associated with moderate to severe active RA.
Tofacitinib is included in a number of RA treatment recommendations, including those published by the European League Against Rheumatism (EULAR), the American College of Rheumatology (ACR) as well as Asia Pacific League of Associations for Rheumatology (APLAR).
Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of XELJANZ through robust clinical development programs in the treatment of immune-mediated inflammatory conditions.
XELJANZ/XELJANZ XR U.S. Label Information
XELJANZ (tofacitinib citrate)/XELJANZ XR (tofacitinib citrate) extended-release 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 US 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 27, 2017. 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 XELJANZ, and an approval for XELJANZ in Europe for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs, including their 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, without limitation, the ability to meet anticipated trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; uncertainties regarding the commercial success of XELJANZ; whether and when any other applications for XELJANZ may be filed with regulatory authorities in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications and/or any other applications that are pending or may be filed for XELJANZ, 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 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, 2016 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.