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%) (p2 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.
