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Xeljanz 5 mg Approved in EU for Treatment of PsA
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The European Commission has approved twice-daily, 5-mg doses of tofacitinib citrate, in combination with methotrexate, for adult patients with psoriatic arthritis who have had an inadequate response or who are intolerant to a prior disease-modifying antirheumatic drug, according to a manufacturer press release.
Tofacitinib citrate (Xeljanz, Pfizer), a JAK inhibitor, was previously approved by the commission in 2017 for the treat moderate-to-severe rheumatoid arthritis in adults with an inadequate response to DMARDs.
“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,” Frank Behrens, MD, from the Division of Rheumatology at Goethe University and Fraunhofer IME-Translational Medicine and Pharmacology in Frankfurt, Germany, said in the release. “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.”
The European Commission based its approval on findings from the phase 3 Oral Psoriatic Arthritis Trials (OPAL) clinical development program in PsA. The program included two studies, OPAL Broaden and OPAL Beyond, as well as data from an ongoing long-term extension trial, OPAL Balance.
“People living with [PsA] may experience a variety of symptoms, making the condition particularly difficult to diagnose and treat,” Angela Lukin, regional president of inflammation and immunology at Pfizer, said in the release. “We are proud that we are now able to offer Xeljanz as an option to adult patients living with active [PsA] in the European Union.”