Pfizer's Arthritis Drug Wins European Approval In Pediatric & Adult Patients
- The European Commission (EC) has approved Pfizer Inc's (NYSE: PFE) Xeljanz (tofacitinib) for active polyarticular juvenile idiopathic arthritis (JIA) and juvenile psoriatic arthritis (PsA).
- The approval covers two years of age and older patients who did not respond 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 to treat polyarticular JIA and juvenile PsA.
- It has received regulatory approval in four indications in the European Union, the most of any JAK inhibitor.
- In addition, the EC has approved Xeljanz prolonged-release 11 mg once-daily tablets for adult patients with active PsA.
- The prolonged-release formulation is for patients who did not respond to methotrexate or other DMARDs.
- Price Action: PFE shares are up 3.08% at $50.22 during the premarket session on the last check Monday
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