FDA posts belatacept briefing documents

FDA posted briefing documents ahead of Monday's Cardiovascular and Renal Drugs Advisory Committee meeting to discuss a BLA from Bristol-Myers Squibb Co. (NYSE:BMY) for belatacept to prevent organ rejection and to preserve a functioning allograft in adult patients receiving renal transplant. In a summary of data from two Phase III trials, FDA noted similar rates of patient and graft survival between belatacept and cyclosporine. However, belatacept had increased rates and higher grades of acute rejection, including a significant difference in one trial.

FDA will ask the panel to vote on whether the benefits outweigh the risks for belatacept. FDA said observed benefits of belatacept included improved blood pressure and reduced rates of new onset diabetes mellitus after transplant. The agency also said belatacept had significantly higher mean glomerular filtration rate (GFR) at 12 months vs. cyclosporine, an efficacy endpoint in the two trials. However, the agency said the relative importance of optimizing GFR in the setting of a kidney transplant remains "controversial." The agency also noted increased rates of post transplant lymphoproliferative disorder (PTLD) and CNS infections with belatacept, including two cases of progressive multifocal leukoencephalopathy (PML), one of which resulted in death. FDA said two occurrences of PML in the context of a drug development program constitute a safety signal. ...