medwireNews: The EMA’s Committee for Medicinal Products for Human Use has recommended approval of upadacitinib for the treatment of rheumatoid arthritis (RA).
The selective Janus kinase 1 inhibitor is recommended, either alone or in combination with methotrexate, for the treatment of adult patients with moderate-to-severe RA and an inadequate response or intolerance to at least one DMARD. It will be available as 15 mg prolonged-release tablets.
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This announcement follows approval of upadacitinib for RA by the US FDA in August 2019.
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