A new drug appears to offer pain relief and increased mobility to rheumatoid arthritis patients who have exhausted their other medical treatment options. A researcher at the Stanford University School of Medicine led a six-month, multicenter clinical trial that found patients were more than twice as likely to have significant improvement with the new drug than with standard therapy. The findings are reported in the Sept. 15 issue of the New England Journal of Medicine.
The study was a phase-III trial, the final stage of human testing normally required by the U.S. Food and Drug Administration before it will consider approving a drug. Based on the results, an FDA advisory panel met on Sept. 6 and recommended the drugs approval for the treatment of rheumatoid arthritis in cases in which standard therapy has failed.
Abatacept, marketed as Orencia, is made by Bristol-Myers Squibb, which sponsored the study. The lead author, Mark Genovese, MD, Stanford associate professor of medicine (immunology and rheumatology), is a paid consultant for the company.
Mitzi Baker | EurekAlert!
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