Xeljanz ® (Tofacitinib Citrate) Receives Marketing Authorization in the European Union for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis
Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has approved XELJANZ ® (tofacitinib) for the treatment of 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 disease modifying antirheumatic drugs (DMARDs). Two formulations were approved, a tablet and a new oral solution (weight-based dosing). XELJANZ is the first and only Janus kinase (JAK) inhibitor approved in Europe for the treatment of polyarticular JIA and juvenile PsA and has received regulatory approval in four indications in the European Union, the most of any JAK inhibitor.
In addition, the EC has approved XELJANZ prolonged-release 11 mg once-daily tablets for the treatment of adult patients with active PsA who have had an inadequate response or intolerance to methotrexate or other DMARDs. This once-daily treatment is an alternative to the currently approved XELJANZ 5 mg twice-daily treatment of PsA.
“Many patients living with polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis require an injection or an infusion when receiving treatment, which can be challenging for both these children and their caretakers,” said Ana Paula Carvalho, International Developed Markets Regional President, Inflammation & Immunology at Pfizer. “We are proud to make these new options available in the EU as Pfizer continues to advance the science and understanding of medicines like XELJANZ, which has been studied in more than 50 trials across clinical programs worldwide.”
JIA is a chronic inflammatory disease of unknown etiology and is defined as arthritis that begins before 16 years of age and persists for at least six weeks. Polyarticular JIA and juvenile PsA are subtypes of JIA. The polyarticular JIA subtype is characterized by arthritis in five or more joints and affects both the small joints of the hands and feet and large joints like the knees, hips and ankles.i People living with the juvenile PsA subtype can have joint symptoms and a scaly rash of the skin.i It is estimated that JIA impacts approximately 60,000 children in Europe.
PsA in adults is a chronic, immune-mediated, inflammatory disease that may include inflammation in peripheral joints, tendons or skin. PsA may include a variety of symptoms such as joint pain and stiffness, swollen toes and/or fingers and reduced range of motion.