In continuation of my update on upadacitinib
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for upadacitinib for the treatment of adult patients with moderate to severe rheumatoid arthritis. Upadacitinib is an investigational once-daily oral JAK1-selective inhibitor being studied for multiple immune-mediated diseases.1-13 AbbVie anticipates a regulatory decision in Q3 2019.
The NDA is supported by data from the global upadacitinib SELECT Phase 3 rheumatoid arthritis program evaluating more than 4,000 patients with moderate to severe rheumatoid arthritis across five of six Phase 3 studies.3-7 In all SELECT Phase 3 studies, upadacitinib met all primary and ranked secondary endpoints. The most frequent serious adverse events were infections.3-7 Top-line results from these clinical studies were previously announced.
Upadacitinib is also under review by the European Medicines Agency for the treatment of adult patients with moderate to severe rheumatoid arthritis.
About the SELECT Study Program
The robust SELECT Phase 3 rheumatoid arthritis program evaluates more than 4,900 patients with moderate to severe rheumatoid arthritis in six studies, five of which support regulatory submission for upadacitinib. The studies include assessments of efficacy, safety and tolerability across a broad range of rheumatoid arthritis patients. Key measures of efficacy evaluated include ACR responses, Disease Activity Score (DAS28-CRP) and inhibition of radiographic progression. More information on these trials can be found at www.clinicaltrials.gov (NCT02706847, NCT03086343, NCT02629159, NCT02706873, NCT02706951, NCT02675426).
About Upadacitinib
Discovered and developed by AbbVie, upadacitinib is an investigational oral, small molecule JAK1-selective inhibitor being studied for moderate to severe rheumatoid arthritis and other immune-mediated diseases.1-2 The FDA granted priority review for AbbVie's NDA for moderate to severe rheumatoid arthritis in Q1 2019. Phase 3 trials of upadacitinib in atopic dermatitis, psoriatic arthritis, Crohn's disease, and ulcerative colitis are ongoing and it is also being investigated to treat ankylosing spondylitis.9-13Upadacitinib is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
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