Tofacitinib gets EMA nod for juvenile arthritis
medwireNews: The EMA’s Committee for Medicinal Products for Human Use has recommended that the indication for tofacitinib should be expanded to include juvenile idiopathic arthritis (JIA) and juvenile psoriatic arthritis (PsA).
Previously approved in Europe for rheumatoid arthritis, PsA, and ulcerative colitis, the committee advises that the Janus kinase (JAK) inhibitor may now be given to patients aged 2 years and older with active polyarticular JIA or juvenile PsA following a previous inadequate response to DMARDs.
The EMA says that tofacitinib should be given in combination with methotrexate for these new indications, or as monotherapy if continued methotrexate treatment is not appropriate.
This announcement follows approval of the JAK inhibitor for JIA by the US FDA in 2020.
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