Pfizer’s Xeljanz wins US nod for psoriatic arthritis
Pfizer Xeljanz and Xeljanz XR have received US marketing clearance for the treatment of adults with active psoriatic arthritis (PsA) who have failed to respond or are intolerant to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
The decision means that the drug is now the first and only Janus kinase (JAK) inhibitor approved by the US Food and Drug Administration for both moderate to severe rheumatoid arthritis (RA) and active PsA, the drug giant highlighted.
Approval came after two Phase III trials assessing Xeljanz (tofacitinib) - OPAL Broaden and OPAL Beyond – hit their primary efficacy targets, showing 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://bit.ly/PfizerXeljanz
The decision means that the drug is now the first and only Janus kinase (JAK) inhibitor approved by the US Food and Drug Administration for both moderate to severe rheumatoid arthritis (RA) and active PsA, the drug giant highlighted.
Approval came after two Phase III trials assessing Xeljanz (tofacitinib) - OPAL Broaden and OPAL Beyond – hit their primary efficacy targets, showing 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://bit.ly/PfizerXeljanz
