FDA Advisory Committee Recommends Approval of Belatacept
The FDA Cardiovascular and Renal Drugs Advisory Committee voted 13-5 in favor of recommending approval of belatacept for the prophylaxis of acute rejection in de novo kidney transplant recipients. Still, members of the committee stressed that long-term follow-up is needed, with some suggesting a registry be used to track patient outcomes if the agent is approved by the FDA. The discussion at the committee meeting centered on the issues inherent in conducting a non-inferiority trial, which was the design used in the Phase 3 trials of belatacept; the potential long-term benefit of the higher glomerular filtration rate observed in patients treated with belatacept versus cyclosporine at Months 12 and 24; and the higher incidences of posttransplant lymphoproliferative disorder and progressive multifocal leukoencephalopathy in the belatacept group.
The FDA is not required to follow advisory committee recommendations, but it often does. Stay tuned to NephrologyTimes.com for more on-the-scene coverage from the meeting.