medwireNews: The US FDA has approved upadacitinib, a selective Janus kinase (JAK)1 inhibitor, for the treatment of patients with moderate-to-severe rheumatoid arthritis (RA) and an inadequate response to methotrexate.
The approval is based on the results of five phase III randomized controlled trials from the SELECT program, which demonstrated the efficacy and safety of upadacitinib in different populations of RA patients.
Upadacitinib will be available as extended-release tablets and is recommended at a dose of 15 mg orally once daily. The JAK inhibitor may be given together with methotrexate or other nonbiologic DMARDs, but the FDA cautions against its use alongside biologic DMARDs, other JAK inhibitors, or potent immunosuppressant therapies such as azathioprine.
The label for upadacitinib includes a boxed warning for serious infection, malignancy, and thrombosis risk.
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