European Commission approves Bristol-Myers Squibb's Orencia for combination use in pJIA

US drug major Bristol-Myers Squibb says that the European Commission has approved Orencia (abatacept) in combination with methotrexate for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA) in pediatric patients six years of age and older who have had an insufficient response to other disease-modifying antirheumatic drugs (DMARDS), including at least one TNF inhibitor. The drug was first approved by the Commission for rheumatoid arthritis in 2007.

Disease-modifying treatment options for children with pJIA have been extremely limited to date. Orencia, in combination with methotrexate (MTX), offers another treatment option for children six years of age and older with pJIA, filling an unmet need. The drug has not been studied in children under six years old. It is designed to act early in the immune cascade by selectively modulating T-cells to reduce downstream inflammatory responses.

Approval based on the AWAKEN study