Bristol-Myers Squibb receives new EU approval for Orencia

Bristol-Myers Squibb has announced that its drug Orencia has been approved by the European Commission in a new indication.

The therapy has been approved for intravenous infusion and subcutaneous injection in combination with methotrexate for the treatment of highly active and progressive cases of rheumatoid arthritis in adults who had not previously been treated with methotrexate.

Studies of Orencia showing its effectiveness among adult patients with high disease activity and poor prognostic factors for rapidly progressive disease provided the clinical trial evidence supporting the recommendation.

The drug is now the first biologic therapy to be approved in Europe specifically for the treatment of methotrexate-naive rheumatoid arthritis patients with highly active and progressive disease.

Brian Gavin, vice-president and Orencia development lead at Bristol-Myers Squibb, said: "The European Commission's approval of Orencia in the EU … is a testament to Bristol-Myers Squibb's commitment to advancing the science of earlier identification of patients with progressive rheumatoid arthritis prior to their suffering debilitating joint damage."

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