Xeljanz approved in fourth indication in the USA

US pharma giant Pfizer (NYSE: PFE) has announced today that the US Food and Drug Administration (FDA) has approved Xeljanz (tofacitinib) to treat children and adolescents aged two years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA).

There were two formulations approved, a tablet and an oral solution, which are dosed based upon weight. This approval makes Xeljanz the first and only Janus kinase (JAK) inhibitor approved in the USA for the treatment of pcJIA.

Hermine Brunner, director of the division of rheumatology at Cincinnati Children’s Hospital Medical Center and Scientific Director of the Pediatric Rheumatology Collaborative Study Group, said: “Although there are already several advanced treatments available, tofacitinib will be an appealing new option given it does not require injections or infusions. These can be quite burdensome to both children with pcJIA and their caretakers. The FDA approval of Xeljanz for pcJIA is positive news for this community as it provides a new advanced treatment option in an oral formulation.”