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PRINCETON, N.J. — The Food and Drug Administration has accepted for review a supplemental approval application for an arthritis drug made by Bristol-Myers Squibb, the drug maker said Monday.
Bristol is seeking approval for Orencia (abatacept) injected into the skin as a treatment for adults with moderate to severe rheumatoid arthritis. The drug already is approved for intravenous injection.
The company filed the application in October after a phase-3 trial program of 1,847 patients showed that patients receiving weekly skin injections of the drug showed about the same degree of improvement as those receiving the drug by IV.