Bristol-Myers Squibb reports Orencia JIA application

Bristol-Myers Squibb has announced that it has filed a supplemental biologics licence application for Orencia (abatacept) as a treatment for paediatric patients suffering from juvenile idiopathic arthritis (JIA).

JIA is a chronic autoimmune condition that results in pain, stiffness and swelling of the joints – potentially resulting in deformities and joint damage.

Filed with the US Food and Drug Administration, the compound aims to help patients with the condition who have exhibited an inadequate response to methotrexate, tumour necrosis factor antagonists or other disease-modifying anti-rheumatic drugs (DMARDs).

The licensing application is based on clinical trial data from a three-stage study involving a four month open-label lead-in treatment period, a six-month randomised double-blind withdrawal phase and an open-label phase where all patients received the compound.

“Orencia, which was discovered and developed by Bristol-Myers Squibb, is currently approved for use in adults with moderate to severe rheumatoid arthritis who have had an inadequate response to one or more DMARDs,” the company reports.

It adds that the compound is a selective modulator of co-stimulatory signals required for the full activation of T-cells.

In June 2007, Bristol-Myers Squibb presented positive results for Orencia at the conference of the European League Against Rheumatism in Barcelona.