medwireNews: The Janus kinase (JAK) inhibitor tofacitinib has been approved by the US FDA for the treatment of polyarticular juvenile idiopathic arthritis (JIA) in patients aged 2 years and older.
Previously approved for the treatment of adults with rheumatoid arthritis, tofacitinib is the first JAK inhibitor to be approved by the FDA for a pediatric population. Two formulations have been approved, namely a 5 mg tablet and a 1 mg/mL oral solution, and the drug is dosed based on weight.
“Although there are already several advanced treatments available [for JIA], tofacitinib will be an appealing new option given [that] it does not require injections or infusions,” said Hermine Brunner, from Cincinnati Children’s Hospital Medical Center in Ohio, USA, in a press release.
The pediatric approval is based on the results of the phase 3 pcJIA-I trial, which demonstrated that 88 JIA patients treated with tofacitinib were significantly less likely to experience disease flares during 44 weeks of follow-up than their 84 counterparts given placebo, at rates of 31% versus 55%.
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