The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for upadacitinib (AbbVie), an investigational oral JAK1-selective inhibitor, for the treatment of moderate to severe rheumatoid arthritis (RA).

The NDA includes data from the SELECT Phase 3 RA program which evaluated more than 4000 patients with moderate to severe RA across 6 studies; 5 of these studies support the NDA submission.  Across these studies, the efficacy of upadacitinib was assessed based on American College of Rheumatology (ACR) responses, Disease Activity Score (DAS28-CRP) and inhibition of radiographic progression, among other measures.

Study results showed that upadacitinib met all primary and ranked secondary endpoints in all SELECT studies; infections were reported as the most frequent serious adverse events.

The FDA is expected to make a decision on the NDA sometime in the third quarter of 2019. In addition to the RA indication, upadacitinib is being investigated as a potential treatment for atopic dermatitis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, and ankylosing spondylitis.

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Currently, 2 other JAK inhibitor therapies are FDA-approved for RA treatment: tofacitinib (Xeljanz, Xeljanz XR; Pfizer), a nonselective JAK inhibitor, and baricitinib (Olumiant; Lilly), a JAK-1/JAK-2 inhibitor. While the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is unknown, selective inhibition may potentially reduce JAK-related side effects.   

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