The European Commission has approved Pfizer’s Xeljanz as a treatment for psoriatic arthritis (PsA), significantly expanding the drug’s scope.
European regulators are allowing use of Xeljanz (tofacitinib citrate) 5mg twice daily in combination with methotrexate for to treat active PsA in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying anti-rheumatic drug (DMARD) therapy.
The decision gives patients the opportunity to access a new treatment approach, as the drug is the first and only oral Janus kinase (JAK) inhibitor to be approved in EU for the condition, which affects between 1.5 and 3 million people in the region.
Approval came on the back of data from the Phase III Oral Psoriatic Arthritis TriaLs (OPAL) clinical development programme, which demonstrated statistically significant improvements in American College of Rheumatology 20 (ACR20) response and change from baseline in the Health Assessment Questionnaire–Disability Index (HAQ-DI) score.
Read more: http://www.pharmatimes.com/news/eu_approves_pfizers_xeljanz_for_psoriatic_arthritis_1242439