The recommendation of the advisory committee makes it likely that the drug will be given final approval by the FDA, although the agency is not bound by the suggestions of its advisory committee.
A previously released FDA document suggested that Bristol-Myers Squibb would need to present extra study data to receive an improvement in physical function claim. However, this does not seem to have prevented the advisory committee recommending the approval of the drug.
Bristol-Myers Squibb completed its submission of a biologics license application (BLA) to the FDA for Orencia (abatacept) in March, and the original FDA action date was October 1, 2005. The FDA has informed Bristol-Myers Squibb that it will require up to 90 additional days to complete the review of the abatacept BLA due to the complexity of the chemistry and manufacturing controls (CMC) section of the application.
The company is currently determining what, if any, impact the BLA delay could have on the timing of a supplemental BLA (sBLA) approval and subsequent broad-scale commercial launch.