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21-08-2019 | Rheumatology | News | Article

approvalsWatch

Upadacitinib gains FDA approval for RA

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.

Click here for a guide to the SELECT trials of upadacitinib in patients with RA 

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.

By Claire Barnard

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group