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Pfizer Inc. announced today that the United States Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) voted 10 to 1 to recommend approval of the proposed dose of tofacitinib for the treatment of adult patients with active psoriatic arthritis (PsA). Pfizer submitted supplemental new drug applications (sNDAs) for XELJANZ® 5 mg twice daily (BID) and XELJANZ® XR extended release 11 mg once daily (QD) for this pending indication. The role of the Advisory Committee is to provide recommendations to the FDA. The FDA decision on whether to approve tofacitinib for PsA is anticipated by December 2017.
“Today marks an important positive step in our journey to potentially bring tofacitinib to adult patients living with active psoriatic arthritis and we are pleased with the Committee’s positive recommendation based on the favorable benefit:risk profile for tofacitinib,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “If approved, tofacitinib would be the first Janus kinase (JAK) inhibitor for psoriatic arthritis. We look forward to working with the FDA to complete review of the applications.”
The AAC discussions were based on Pfizer’s applications for tofacitinib in PsA, which are currently under review by the FDA. These include data from the tofacitinib Phase 3 trials in PsA, as well as additional safety analyses from the broader tofacitinib clinical development program.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic, autoimmune, inflammatory disease that includes manifestations in peripheral joints, tendons, ligaments, bone and skin. PsA may include a variety of symptoms such as joint pain and stiffness, swollen toes and fingers, persistent painful tendonitis, irreversible joint damage and reduced range of motion. The disease usually appears between the ages of 30 to 50, equally between men and women, and can limit daily activities.
About Tofacitinib Citrate
Tofacitinib citrate is a Janus kinase (JAK) inhibitor. It is not currently approved for the treatment of PsA.
As the developer of tofacitinib, Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of tofacitinib 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. In rheumatoid arthritis, 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
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.
Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is as of August 3, 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 a potential new indication for XELJANZ and XELJANZ XR for the treatment of adult patients with active psoriatic arthritis (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, 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 and XELJANZ XR; whether and when any other applications for the potential indication or any other potential indications for XELJANZ or XELJANZ XR may be filed with regulatory authorities in any jurisdictions; whether and when the FDA may approve the supplemental new drug applications for XELJANZ and XELJANZ XR for the potential indication and whether and when regulatory authorities in any jurisdictions may approve any other applications that may be filed or pending for XELJANZ or XELJANZ XR, 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, including the potential indication; 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.
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