Bristol-Myers Squibb’s Orencia recommended by CHMP for new indication

Bristol-Myers Squibb has announced that its biologic therapy Orencia has been recommended for EU approval in a new indication.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending the approval of Orencia as an intravenous infusion and subcutaneous injection, in combination with methotrexate, for cases of highly active and progressive rheumatoid arthritis in adult patients.

This would allow the drug to be used in patients who have not previously been treated with methotrexate, making it the first biologic therapy with an EU indication specifically applicable to the treatment of methotrexate-naive rheumatoid arthritis patients with highly active and progressive disease.

Clinical studies of Orencia involving patients with high disease activity accompanied by poor prognostic factors for rapidly progressive disease were used to support the recommendation.

Brian Gavin, vice-president and Orencia's development lead at Bristol-Myers Squibb, said: "The potential to provide a biologic treatment option in the EU for methotrexate-naive rheumatoid arthritis patients who have highly active and progressive disease is clinically significant, and we look forward to the European Commission decision."

The firm also applied for regulatory approval of its drug Opdivo as a treatment for previously treated recurrent or metastatic squamous cell carcinoma of the head and neck in the US and Europe earlier this month.