Drug Development

U.S. FDA panel recommends approval of rheumatoid arthritis drug

Published in Medical Letter on the CDC and FDA, October 9th, 2005

Bristol-Myers Squibb Company (BMY) announced that the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee unanimously (7-0) recommended approval of Orencia (abatacept), the company's investigational selective modulator of T-cell costimulation under development for the treatment of rheumatoid arthritis (RA).

T-cell activation plays an important role in the immunopathogenesis of RA. The company presented preclinical and clinical data, and discussed the proposed pharmacovigilance program. The FDA is not bound by the committee's recommendations.

Bristol-Myers Squibb completed its submission of a biologics license application (BLA) to...

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Source: Medical Letter on the CDC and FDA (2005-10-09)

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