Bristol Orencia launch
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Bristol-Myers Squibb plans to launch its rheumatoid arthritis biologic Orencia (abatacept) in early 2006, the firm says during its third-quarter earnings call Oct. 28. The company expects approval "soon"; FDA extended its Oct. 1 user fee date by 90 days due to complex chemistry, manufacturing and controls sections of the BLA (1Pharmaceutical Approvals Monthly September 2005, In Brief). A full-scale launch will not be possible until FDA approves a third-party manufacturing facility; BMS plans to file an sBLA for the facility post-approval. FDA's Arthritis Drugs Advisory Committee unanimously recommended the first-in-class T-cell co-stimulation modulator for approval Sept. 6...