Bristol-Myers Squibb is celebrating the news that regulators in the USA have given the go-ahead for a change on the labelling of its rheumatoid arthritis drug Orencia.

The US Food and Drug Administration has approved an addition to the label which includes data from the AGREE trial which demonstrated that Orencia (abatacept) is effective for patients who have suffered from RA for two years or less. The agency gave the green light to the drug at the end of 2005 for patients with moderate to severe RA who did not respond to treatment with other drugs, notably methotrexate.

B-MS quoted AGREE lead investigator Rene Westhovens of the Catholic University in Leuven, Belgium as saying that the updated labelling “is important for rheumatologists as they consider whether Orencia is an appropriate treatment for their new-to-biologic adult patients. Data have shown that the drug can inhibit radiographic progression of RA “and improve physical function and health-related quality of life in addition to relieving pain, swelling and fatigue”.

The New York-headquartered firm will be hoping that the label change helps the drug compete more effectively against big-selling tumour necrosis factor blockers such as Johnson & Johnson and Schering-Plough's Remicade (infliximab), Amgen and Wyeth's Enbrel (etanercept) and Abbott Laboratories' Humira (adalimumab). Second-quarter sales of Orencia increased 40% to $148 million.