EMA gives nod to upadacitinib for psoriatic arthritis, ankylosing spondylitis
medwireNews: The EMA’s Committee for Medicinal Products for Human Use has recommended that the indication for upadacitinib should be expanded to include psoriatic arthritis (PsA) and ankylosing spondylitis (AS).
Previously approved for rheumatoid arthritis, the Janus kinase (JAK) inhibitor is now indicated for the treatment of active PsA, either as monotherapy or in combination with methotrexate, in adult patients with an inadequate response or intolerance to one or more DMARDs. Upadacitinib may also be given to adult patients with AS and an inadequate response to conventional therapy.
The clinical benefits of upadacitinib in PsA were demonstrated in the phase 3 SELECT-PsA-1 and SELECT-PsA-2 trials, involving patients with and without prior exposure to biologics, while the phase 2/3 SELECT-AXIS 1 trial showed that the JAK inhibitor improves outcomes for patients with AS and previous exposure to nonsteroidal anti-inflammatory drugs.
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