Bristol Orencia review extension
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA's revised user fee date for Bristol-Myers Squibb's rheumatoid arthritis biologic Orencia (abatacept) is Dec. 29, Bristol says Sept. 6 after the Arthritis Drugs Advisory Committee's unanimous recommendation for approval. The 90-day extension of the original Oct. 1 action date for the T-cell costimulation modulator was "due to the complexity of the chemistry and manufacturing controls section of the application," BMS says, adding that it plans to file an sBLA for a second Orencia manufacturing facility "at the earliest possible date following BLA approval." Bristol appears to be setting the stage to differentiate Orencia from the RA-approved tumor necrosis factor inhibitors (Humira, Enbrel and Remicade). During the advisory committee meeting, the firm suggested that abatacept interferes earlier than the TNF agents in RA pathogenesis and as a result may have a broader mechanism of action...