Pfizer announced in a statement that the prespecified non-inferiority criteria for a post-marketing safety study of the rheumatoid arthritis drug Xeljanz (tofacitinib) were not met, but the company remains hopeful that future analyses of the study will be more promising.
Eli Lilly is planning to seek another regulatory approval for Taltz after the medication hit the primary and secondary endpoints in a Phase III study for non-radiographic axial spondyloarthritis.
Pfizer Inc. announced that the European Commission approved Xeljanz (tofacitinib citrate) 10 mg twice daily for at least eight weeks, followed by Xeljanz 5 mg BID or 10 mg BID, for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
The European Commission approved Pfizer’s Xeljanz in combination with methotrexate for treating active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
