Sales of Bristol-Myers Squibb’s Orencia could be in for a boost after regulators in Europe backed earlier use of the rheumatoid arthritis drug.
The European Commission has approved a new indication for Orencia (abatacept) in combination with methotrexate for the treatment of moderate to severe active RA in adults who have responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including MTX or a tumor necrosis factor-alpha inhibitor. The approval was supported by results of the two-year AGREE study in MTX-naive, as well as long-term open-label data from the AIM, ATTEST, ATTAIN and ARRIVE studies and a Phase IIb clinical trial.
Manuela Le Bars, B-MS’ European medical lead for immunoscience, said there is “a growing body of evidence to show that earlier use of Orencia may have significant benefits for patients – for both short-term and long-term efficacy”. She added that this new indication “means patients have the potential to benefit sooner from incremental improvements in function and quality of life”.
Orencia, which in combination with MTX, is also indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in paediatric patients aged six and older, had first-quarter sales of $169 million,up 36%.
