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Xeljanz (tofacitinib citrate) receives marketing authorisation in the EU for active Psoriatic Arthritis

The European Commission has approved XELJANZ (tofacitinib citrate) 5 mg twice daily (BID) in combination with methotrexate (MTX) for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.  XELJANZ is the first and only oral Janus kinase (JAK) inhibitor to be approved in the European Union (EU) for the treatment of adults with active PsA. In 2017, XELJANZ in combination with MTX was approved in the EU 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 DMARDs.

“People living with psoriatic arthritis may experience a variety of symptoms, making the condition particularly difficult to diagnose and treat,” said Angela Lukin, Regional President, Inflammation and Immunology, Pfizer. “We are proud that we are now able to offer XELJANZ as an option to adult patients living with active psoriatic arthritis in the European Union.”

“Psoriatic arthritis, a chronic inflammatory condition which affects between 1.5 and 3 million people in Europe, causes joint pain and swelling that can eventually lead to permanent joint damage if not diagnosed and treated sufficiently early on,” said Frank Behrens, Rheumatology at Goethe University and Fraunhofer IME-Translational Medicine & Pharmacology, Frankfurt, Germany. “This approval for XELJANZ is an important milestone for the psoriatic arthritis community, who are in need of an additional oral treatment option to help manage their condition.”

Psoriatic arthritis (PsA) is a chronic, autoimmune, inflammatory disease that may include manifestations in peripheral joints, tendons, ligaments 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.

XELJANZ® (tofacitinib citrate) is the first and only Janus kinase (JAK) inhibitor approved by the FDA for three indications in adults: moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA) and moderately to severely active ulcerative colitis (UC). XELJANZ is now approved in more than 80 countries for the treatment of adult patients with moderate to severe RA, with additional applications pending globally for all three respective indications.

As the developer of XELJANZ, Pfizer is committed to advancing JAK science and enhancing understanding of XELJANZ through robust clinical development programs in the treatment of immune-mediated inflammatory condition.

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