Bristol-Myers Squibb’s Orencia (abatacept) has secured marketing approval in the EU to treat paediatric patients.
The drug has been authorised by the European Commission in combination with methotrexate for children with moderate to severe polyarticular juvenile idiopathic arthritis (pJIA).
It is indicated for children six years of age and older who have not responded to other disease-modifying anti-rheumatic drugs (DMARDs), including at least one tumour necrosis factor (TNF) inhibitor.
The approval is based on findings from the AWAKEN study (Abatacept Withdrawal study to Assess efficacy and safety in Key Endpoints in juvenile idiopathic arthritis Not responding to current treatment).
JIA is the most common form of arthritis affecting children and an important cause of short-term and long-term disability in children.
Orencia was the first biologic discovered and developed in Bristol-Myers Squibb’s research centres, and was approved for adult rheumatoid arthritis (RA) in May 2007 by the European Commission. It is designed to prevent full T-cell activation and inhibit the release of chemicals that lead to the joint inflammation and destruction observed in RA and pJIA.