Bristol-Myers Squibb Gets CHMP's Positive Opinion For ORENCIA

Bristol-Myers Squibb Company BMY disclosed the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has provided a positive opinion. According to the company, the regulator recommended the approval of ORENCIA intravenous (IV) infusion and subcutaneous (SC) injection, in combination with methotrexate, for the treatment of rheumatoid arthritis on adults not previously treated with MTX.

Bristol-Myers said this CHMP recommendation would be reviewed by the European Commission (EC). The company indicated that if the drug gets the EU approval for this new indication, ORENCIA would be the first biologic therapy with an EU indication specifically applicable to the treatment of MTX-naive RA patients.

The company pointed out those ORENCIA trials involving patients with high disease activity accompanied by poor prognostic factors for rapidly progressive disease provided the clinical study proof supporting the recommendation.

VP for ORENCIA Development Lead, Brian Gavin, said, "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."

He added, "The potential to provide a biologic treatment option in the EU for MTX-naive RA patients who have highly active and progressive disease is clinically significant, and we look forward to the European Commission decision."