Upadacitinib Gets FDA’s Priority Review for Treatment of Moderate to Severe RA

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.

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.   

For more information visit AbbVie.com.