The European Commission granted expanded approval to Bristol-Myers Squibb's Orencia (abatacept), in combination with methotrexate (MTX), for the treatment of moderate-to-severe active rheumatoid arthritis in patients who have not responded to previous therapy, including TNF-alpha inhibitors, the company announced Wednesday.
The drugmaker noted that the decision was supported by results of the two-year AGREE study, as well as long-term open-label data from the AIM, ATTEST, ATTAIN and ARRIVE studies and a Phase IIb clinical trial. In the ARRIVE study, 53 percent of patients with RA who received Orencia and MTX had an improvement in their disease after six months, compared to 38 percent who received MTX alone. Similar findings were observed in the other studies. Manuela Le Bars, Bristol-Myers Squibb's European Medical Lead for Immunoscience, noted that "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."
The drug, which had first-quarter sales of $169 million, was first approved to treat RA in Europe in 2007, and is also approved in the US.
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