Bristol-Myers Squibb receives approval for new Orencia indication

Bristol-Myers Squibb’s rheumatoid arthritis treatment Orencia has been approved for a new indication by the European Commission.

The regulatory body has ratified the abatacept-based treatment in combination with methotrexate (MTX) among rheumatoid arthritis patients who have proven unresponsive to one or more disease-modifying anti-rheumatic drugs, including MTX or a TNF-alpha inhibitor.

Orencia’s efficacy and safety profile has been underlined by results from a number of clinical trials, including the recent Attest study, in which it was shown to provide superior results to infliximab.

Dr Manuela Le Bars, European medical lead for immunoscience at Bristol-Myers Squibb, said the approval was welcome news for patients due to evidence from these studies that earlier use of Orencia can deliver improved outcomes.

She added: “This new indication means patients have the potential to benefit sooner from incremental improvements in function and quality of life provided by Orencia.”

Last week, the company published positive clinical data from a trial of the type 2 diabetes mellitus treatment Onglyza, which was developed in collaboration with AstraZeneca.