European Commission approves new RA treatment from BMS
pharmafile | September 6, 2016 | News story | Research and Development, Sales and Marketing | BMS, Bristol-Myers Squibb, EMA, EU, Orencia, RA, abatacept, approval, rheumatoid arthritis
Bristol-Myers Squibb has received approval from the European Commission for rheumatoid arthritis (RA) treatment Orencia (abatacept), making it the first biologic with an EU indication specifically applicable to the treatment of methotrexate-naiive RA patients.
The intravenous infusion and subcutaneous injection of methotrexate has been approved, in combination with methotrexate, for the treatment of highly active and progressive disease in adult patients with RA.
Originally indicated for patients with juvenile idiopathic arthritis, this expanded approval will allow adult patients to benefit from this therapy when the disease is progressing rapidly.
The approval is based on Phase III data which showed that treatment with Orencia demonstrated significant efficacy versus methotrexate alone in moderate to severe RA. Significantly more patients achieved remission as defined by disease activity scores for RA, called DAS28-CRP, with Orencia in the AVERT and AGREE trials.
Brian Gavin, Orencia development lead at Bristol-Myers Squibb, says: “Across the globe we remain committed to advancing care for those living with RA. The European Commission’s approval of Orencia in the EU for MTX-naïve RA patients who have highly active and progressive disease is a testament to Bristol-Myers Squibb’s commitment to advancing the science of earlier identification of patients with progressive RA prior to their suffering debilitating joint damage.”
Sean Murray
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