Pfizer's Arthritis Drug Wins European Approval In Pediatric & Adult Patients

  • The European Commission (EC) has approved Pfizer Inc's 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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Posted In: BiotechNewsHealth CareFDAGeneralArthritisBriefseuropean medical agency
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