Summary of the US FDA Approval of Belatacept

Elements of the Food and Drug Administration (FDA) review of the clinical data that supported the approval of the Biologics License Application (BLA) for belatacept for prophylaxis of organ rejection in adult patients receiving a kidney transplant are summarized. The article is not intended as a comprehensive summary of the entire belatacept data submission. Rather, the discussion is meant to illustrate aspects of the FDA's process for evaluating efficacy and safety, using belatacept as an example. The authors discuss the clinical data that were used to support the approval of belatacept in order to illustrate the Food and Drug Administration's process for evaluating products for efficacy and safety. See editorial by Vincenti on page 513, and related article by Medina Pestana et al on page 630.