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Bristol Orencia review

Executive Summary

Bristol-Myers Squibb's abatacept, with proposed trade name Orencia, will be reviewed by FDA's Arthritis Drugs Advisory Committee on Sept. 6 for treatment of moderately to severely active rheumatoid arthritis. Abatacept is a first-in-class selective T-cell co-stimulation modulator. Bristol completed a rolling BLA (125118/0) for abatacept at the end of March. The company has requested a priority review, which means the biologic could be approved by the end of September. The meeting will be held in the CDER advisory committee conference room at 5630 Fishers Lane in Rockville, Md. beginning at 8:30 a.m...
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PS046107

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