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AbbVie Submits Regulatory Application To FDA For RINVOQ For The Treatment Of Adults With Active Ankylosing Spondylitis

NORTH CHICAGO, Ill., Aug. 25, 2020 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced that it has submitted an application for a new indication to the U.S. Food and Drug Administration (FDA) for RINVOQ™

Benzinga · 08/25/2020 12:47

NORTH CHICAGO, Ill., Aug. 25, 2020 /PRNewswire/ -- AbbVie (NYSE:ABBV) today 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.

"Ankylosing spondylitis is a debilitating disease that can cause severe pain, restricted mobility and lasting structural damage. With limited treatment options, innovation is crucial to help more patients living with active ankylosing spondylitis reach their treatment goals," said Michael Severino, M.D., vice chairman and president, AbbVie. "RINVOQ has the potential to improve care by helping to provide disease control, addressing pain and improving function. We look forward to working with regulatory authorities and hope to bring this important treatment option to patients."

The applications to the FDA and EMA are supported by data from SELECT-AXIS 1, a Phase 2/3 study in which RINVOQ demonstrated significant improvements in signs and symptoms in patients with active ankylosing spondylitis.1 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).1 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.2-4

Ankylosing spondylitis is a chronic, progressive, inflammatory musculoskeletal disease impacting more than five million people worldwide.5,6 The range of symptoms pose significant physical, psychological and economic burden on individuals impacted by the disease.5,7-9