An advisory panel to the FDA will be meeting to discuss whether or not to recommend approval of belatacept in the US to prevent organ rejection and maintain kidney function in patients post renal transplantation.  FDA staff noted that trial data indicated improvements in cardiac risks and kidney function with treatment, but several cases of post-transplantation complication and progressive multifocal leukoencephalopathy gave cause for concern. Therefore they advised in documents released ahead of the meeting that “careful consideration should be given to whether the data regarding the observed benefits associated with the belatacept regimen outweigh the risks of higher mortality and excess morbidity." A final approval decision from the FDA is expected by May 2010. Recent phase III data were published in the American Journal of Transplantation (see link below).