AbbVie has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for upadacitinib, an oral investigational JAK1-selective inhibitor, for the treatment of adult patients with moderate to severe rheumatoid arthritis.
"AbbVie is committed to advancing care for the millions of people living with rheumatoid arthritis, many of whom still do not achieve their treatment goals," said Michael Severino, M.D., Vice Chairman and President, AbbVie. "If approved, upadacitinib has the potential be a meaningful treatment option for a broad range of rheumatoid arthritis patients. We look forward to working with the regulatory authorities throughout the review process."
The NDA and MAA are 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 Phase 3 studies. In all studies, upadacitinib met all primary and ranked secondary endpoints. The most frequent serious adverse events were infections. Top-line results from these clinical studies were previously announced. Upadacitinib is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
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The robust SELECT Phase 3 rheumatoid arthritis program evaluates more than 4,900 patients with moderate to severe rheumatoid arthritis in six studies. 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.
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. Phase 3 trials of upadacitinib in psoriatic arthritis, Crohn's disease, atopic dermatitis and ulcerative colitis are ongoing and it is also being investigated to treat ankylosing spondylitis. Upadacitinib is not approved and its safety and efficacy have not been evaluated by regulatory authorities.