CHMP issues positive opinion for Orencia combined with methotrexate for treatment of RA

Bristol-Myers Squibb Company announced Orencia intravenous infusion and subcutaneous injection in combination with methotrexate has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency recommending approval of the therapy for treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate.

According to a press release, the positive opinion released by the Committee for Medical Products for Human Use (CHMP) was based on two phase 3 studies that showed Orencia (abatacept, Bristol-Myers Squibb) IV plus methotrexate had significant efficacy and that more patients achieved remission with the subcutaneous combination therapy vs. methotrexate (MTX) alone. Orencia would be the first biologic therapy with a European Union indication specifically applicable to the treatment of methotrexate-naïve patients with rheumatoid arthritis (RA) with highly active and progressive disease if it is approved for this new indication, the release noted.

“The CHMP’s recommendation for Orencia is a milestone built on Bristol-Myers Squibb’s commitment to advancing the science of earlier identification of patients with progressive RA prior to their suffering debilitating joint damage,” Brian J. Gavin, vice president of the Orencia development lead at Bristol-Myers Squibb, said in the release. “The potential to provide a biologic treatment option in the EU for MTX-naïve RA patients who have highly active and progressive disease is clinically significant, and we look forward to the European Commission decision.”

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