Bristol-Myers Squibb Co. (BMY) said that the European Commission approved Orencia in combination with methotrexate for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in paediatric patients six years of age and older that have had an insufficient response to other DMARDS, including at least one TNF inhibitor.
The approval of ORENCIA in pJIA is based on findings from the double-blind, randomised controlled study AWAKEN or Abatacept Withdrawal study to Assess efficacy and safety in Key Endpoints in juvenile idiopathic arthritis Not responding to current treatment.
The study evaluated the efficacy and safety of ORENCIA in patients six to 17 years of age with moderate to severe active pJIA who had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs), such as MTX or tumour necrosis factor (TNF) antagonists.
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