Rinvoq filed with FDA and MAA for active ankylosing spondylitis.- AbbVie

AbbVie announced that it has submitted an application for a new indication to the U.S. Food and Drug Administration (FDA) for Rinvoq (upadacitinib; 15 mg, once daily), a selective and reversible JAK inhibitor, for the treatment of adult patients with active ankylosing spondylitis. AbbVie also submitted an application to the European Medicines Agency (EMA) for Rinvoq earlier this year for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy. The applications to the FDA and EMA are supported by data from SELECT-AXIS 1, a Phase II/III study in which RINVOQ demonstrated significant improvements in signs and symptoms in patients with active ankylosing spondylitis. In this study, twice as many patients receiving Rinvoq (52 percent) met the primary endpoint of Assessment of SpondyloArthritis International Society (ASAS) 40 response versus placebo (26 percent) at week 14 (p<0.001). the safety profile of rinvoq in ankylosing spondylitis was consistent with previously reported studies across therapeutic areas, including rheumatoid arthritis, atopic dermatitis and psoriatic arthritis, with no new significant safety risks detected.>