New indication cleared in Europe for Orencia

6 September 2016

The European Commission has approved Orencia (abatacept) intravenous (IV) infusion and subcutaneous (SC) injection, in combination with methotrexate (MTX), for the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis (RA) not previously treated with MTX.

With this approval, Orenciais the first biologic therapy with an indication in the European Union (EU) specifically applicable to the treatment of MTX-naive RA patients with highly active and progressive disease, noted US pharma major Bristol-Myers Squibb (NYSE: BMY), which developed and markets the drug.

Studies of Orencia involving adult patients with high disease activity (mean DAS28-CRP of 5.4) accompanied by poor prognostic factors for rapidly progressive disease (positive for anti-CCP antibodies (also known as ACPA), and/or RF+, presence of baseline joint erosions) provided the clinical trial evidence supporting the recommendation. This approval allows for the expanded marketing of Orencia in all 28 member states of the EU.

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