BRIEF—EC approval of Pfizer's Xeljanz for JIA and PsA

21 August 2021

The European Commission (EC) has approved US pharma giant Pfizer’s Xeljanz (tofacitinib) for the treatment of active polyarticular juvenile idiopathic arthritis (JIA) and juvenile psoriatic arthritis (PsA) in patients two years of age and older who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs).

Two formulations were approved, a tablet and a new oral solution (weight-based dosing).

Xeljanz is the first and only Janus kinase (JAK) inhibitor approved in Europe for the treatment of polyarticular JIA and juvenile PsA and has received regulatory approval in four indications in the European Union, the most of any JAK inhibitor, said Pfizer.

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