Singapore, April 9, 2008: The US Food and Drug Administration has approved Orencia (abatacept), manufactured by New York-based Bristol-Myers Squibb, for reducing signs and symptoms in pediatric patients six years and older with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA).

 

Orencia may be used as monotherapy or concomitantly with methotrexate (MTX). Orencia should not be administered along with with tumor necrosis factor (TNF) antagonists and is not recommended for use with other biologic rheumatoid arthritis (RA) therapy, such as anakinra. This new indication for Orencia provides significant evidence of its durable efficacy and long-term safety in pediatric patients, including those initiating biologic therapy for the first time. The safety and efficacy of Orencia in JIA were assessed in a three-part study through one year.

 

The approval is based on the AWAKEN (abatacept withdrawal study to assess efficacy and safety in key endpoints in juvenile idiopathic arthritis not responding to current treatment) trial.

 

According to Dr Elliott Sigal, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb, juvenile idiopathic arthritis is the most prevalent form of arthritis in children. This new indication for Orencia offers another treatment option to help improve signs and symptoms of this serious disease in pediatric and adolescent patients.