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AbbVie submitted a marketing application to the U.SFood and Drug Administration (FDA) and the European Medicines Agency (EMA) for a new indication of its JAK2 inhibitor, Rinvoq (upadacitinib), for the treatment of adult patients with active psoriasis arthritisbased on data from two phase III studies involving more than 2,000 patientsin both studies, Rinvoq reached the primary endpoint of the ACR20 reaction at week 12 compared to placebo, and also achieved a non-disadvantagegoal in the 12th week relative to the anti-tumor necrosis factor, single anti-amumabthe company noted that physical function (HAQ-DI) and skin symptoms (PASI 75) in patients treated with Rinvoq have also improved betterMichael Severino, AbbVie Vice Chairman and President, said: "Psoriasis arthritis is a complex heterogeneous disease that has symptoms in multiple tissues, including joints and skin, leading to pain, fatigue and stiffness"
" we look forward to working with regulators to bring Rinvoq into this category as soon as possibleRinvoq is a selective and reversible JAK inhibitor that is being studied in a variety of immunomediated inflammatory diseasesThe drug was approved last year to treat adult patients with moderate to severe active rheumatoid arthritis who had poor response to or intolerant resistance to one or more disease-relieving anti-rheumatism drugs
