Pfizer’s XELJANZ® (tofacitinib) Receives Marketing Authorization in the European Union for the Treatment of Active Ankylosing Spondylitis

NEW YORK, NY, USA I November 18, 2021 I Pfizer Inc. (NYSE: PFE) announced today that the European Commission has approved XELJANZ® (tofacitinib) 5 mg twice daily for the treatment of adults with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.

XELJANZ is the first and only oral Janus kinase (JAK) inhibitor approved for five indications in the European Union (EU), including in adults with moderate to severe active rheumatoid arthritis (RA), adults with active psoriatic arthritis (PsA), adults with moderately to severely active ulcerative colitis (UC), and patients 2 years of age or older with active polyarticular juvenile idiopathic arthritis (pcJIA) and juvenile psoriatic arthritis (PsA).

“Ankylosing spondylitis is a debilitating and chronic immuno-inflammatory disease that affects the lives of more than one million people in the EU who are in need of additional treatment options,” 1 said Ana Paula Carvalho, International Developed Markets Regional President, Inflammation & Immunology at Pfizer. “We are proud to make XELJANZ, a medicine that does not require an injection or an infusion, available to patients and their healthcare providers to help address this unmet medical need.”

The approval of XELJANZ for AS is based on data from a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of tofacitinib 5 mg twice daily versus placebo in 269 adult patients living with active AS. The study met its primary endpoint showing that at week 16, the percentage of patients achieving an Assessment in SpondyloArthritis International Society (ASAS) 20 response was significantly greater with tofacitinib (56.4%) versus placebo (29.4%) (p<0.0001). In addition, the percentage of ASAS40 response was significantly greater with tofacitinib (40.6%) versus placebo (12.5%) (p<0.0001), a key secondary endpoint of the study.2 ASAS20/40 are used for defining improvement or response to treatment.3 In general, the types of adverse drug reactions in patients with ankylosing spondylitis were consistent with the known safety profile of XELJANZ.

XELJANZ has been studied in more than 50 clinical trials worldwide, including more than 20 trials in RA patients, and prescribed to over 300,000 adult patients (the majority of whom were RA patients) since 2012.4,5,6

About XELJANZ® (tofacitinib)

XELJANZ (film-coated immediate release tablet, twice daily dosing) is the first and only oral JAK inhibitor approved in the European Union in five indications: adults with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy, adults with moderately to severely active rheumatoid arthritis (RA) after disease modifying antirheumatic drug (DMARD) failure or intolerance, adults with active PsA after DMARD failure or intolerance, adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent, and active polyarticular juvenile idiopathic arthritis (JIA) and juvenile psoriatic arthritis (PsA) in patients two years of age and older who have responded inadequately to previous therapy with DMARDs.

XELJANZ has been studied in more than 50 clinical trials worldwide, including more than 20 trials in RA patients, and prescribed to over 300,000 adult patients (the majority of whom were RA patients) worldwide since 2012.4,5,6 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.

In June 2021, the Committee for Medicinal Products for Human (CHMP) Use of the European Medicines Agency adopted a recommendation from the Pharmacovigilance Risk Assessment Committee (PRAC) following the PRAC review of the co-primary endpoints data from ORAL Surveillance, which states that in patients over 65 years of age, patients who are current or past smokers, patients with other cardiovascular (CV) risk factors, and patients with other malignancy risk factors, XELJANZ should only be used if no suitable treatment alternatives are available. The updated summary of product characteristics reflecting the CHMP-endorsed PRAC recommendation is now effective and is applicable to all EU member states. PRAC’s review of the complete ORAL Surveillance data is ongoing.

In September 2021, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication (DSC) related to XELJANZ/XELJANZ XR and two other arthritis medicines in the same drug class, based on its complete review of the ORAL Surveillance trial. More information is available on the DSC here. Pfizer is continuing to work with the FDA, EMA, and other regulatory agencies to update XELJANZ labeling across the world, in light of the ORAL Surveillance data.

About Ankylosing Spondylitis (AS)

AS is a chronic, inflammatory disease that affects men and women in early adulthood. The first symptoms usually occur before the age of 30 and seldom occur after the age of 45. Symptoms of AS include chronic pain and stiffness in the back and hips for those living with the disease and can negatively impact health-related quality of life.7 Over time, some patients may experience fusion of the vertebrae in the spinal column.8 According to studies, approximately more than one million people in the European Union live with AS.1

U.S. FDA-APPROVED INDICATIONS

Rheumatoid Arthritis

  • XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
  • Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Psoriatic Arthritis

  • XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other DMARDs.
  • Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Ulcerative Colitis

  • XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or who are intolerant to TNF blockers.
  • Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Polyarticular Course Juvenile Idiopathic Arthritis

  • XELJANZ/XELJANZ Oral Solution is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older.
  • Limitations of Use: Use of XELJANZ/XELJANZ Oral Solution in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Please see full Prescribing Information, including BOXED WARNING for XELJANZ available at: www.xeljanzpi.com.

About Pfizer Inflammation & Immunology

At Pfizer Inflammation & Immunology, we strive to deliver breakthroughs that enable freedom from day-to-day suffering for people living with autoimmune and chronic inflammatory diseases, which can be debilitating, disfiguring and distressing, dramatically affecting what they can do. With a focus on Rheumatology, Gastroenterology and Medical Dermatology, our current portfolio of approved medicines and investigational molecules spans multiple action and delivery mechanisms, from topicals to small molecules, biologics and biosimilars. Our differentiated R&D approach resulted in one of the broadest pipelines in the industry, where we purposefully match molecules to diseases where we believe they can make the biggest difference. Building on our decades-long commitment and pioneering science, we continue to advance the standard of care for patients with these debilitating diseases and are working hand-in-hand with patients, caregivers and the broader healthcare community on healthcare solutions for the many challenges of managing chronic inflammatory diseases, allowing patients to live their best lives. To learn more, visit www.pfizer.com/science/immunology-inflammation.

Pfizer Inc.: Breakthroughs that change patients’ lives®

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, including innovative medicines and vaccines. 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 170 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.

1 Dean LE, Jones GT, MacDonald AG, Downham C, Sturrock RD, Macfarlane GJ. Global prevalence of ankylosing spondylitis. Rheumatology (Oxford). 2014 Apr;53(4):650-7. doi: 10.1093/rheumatology/ket387. Epub 2013 Dec 9. PMID: 24324212. https://academic.oup.com/rheumatology/article/53/4/650/1841972
2 Deodhar A, Sliwinska-Stanczyk P, Xu H, Baraliakos X, Gensler LS, Fleishaker D, Wang L, Wu J, Menon S, Wang C, Dina O, Fallon L, Kanik KS, van der Heijde D. Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2021 Apr 27;80(8):1004–13. doi: 10.1136/annrheumdis-2020-219601. Epub ahead of print. PMID: 33906853; PMCID: PMC8292568.
3 Landewé R, van Tubergen A. Clinical Tools to Assess and Monitor Spondyloarthritis. Curr Rheumatol Rep. 2015;17(7):47. doi:10.1007/s11926-015-0522-3
4 Pfizer Data on File. XELJANZ Worldwide Registration Status.
5 ClinicalTrials.gov. Tofacitinib RA Studies. Accessed June 25, 2020.
6 Pfizer. Data on File. Tofa Counts. April 2019
7 University of Maryland Medical Center. A Patient’s Guide to AS. Accessed August 2021. Available at: https://www.umms.org/ummc/health-services/orthopedics/services/spine/patient-guides/ankylosing-spondylitis
8 Exarchou S, Lindström U, Askling J, et al. The prevalence of clinically diagnosed ankylosing spondylitis and its clinical manifestations: a nationwide register study. Arthritis Res Ther. 2015;17(1):118. Published 2015 May 9. doi:10.1186/s13075-015-0627-0 https://pubmed.ncbi.nlm.nih.gov/25956915/

SOURCE: Pfizer

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