NEW YORK CITY (dpa-AFX) - Bristol-Myers Squibb Co. (BMY) Tuesday said the European Commission has approved Orencia intravenous infusion and subcutaneous injection, in combination with methotrexate or MTX for the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with MTX.
This approval allows for the expanded marketing of Orencia in all 28 Member States of the EU to the treatment of MTX-naive RA patients with highly active and progressive disease.
The approval was based on data from two Phase 3 studies. Studies showed that in adult patients involving with high disease activity accompanied by poor prognostic factors for rapidly progressive disease and/or RF+ presence of baseline joint erosions provided the clinical trial evidence supporting the recommendation.
Rheumatoid arthritis is a systemic, chronic, autoimmune disease characterized by inflammation in the lining of joints, causing joint damage with chronic pain, stiffness, and swelling in the joints.
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