title: Summary of the US FDA approval of belatacept.
abstract: 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.
authors.affiliation: Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: P
authors.initials: P
authors.lastname: Archdeacon
authors.forename: C
authors.initials: C
authors.lastname: Dixon
authors.forename: O
authors.initials: O
authors.lastname: Belen
authors.forename: R
authors.initials: R
authors.lastname: Albrecht
authors.forename: J
authors.initials: J
authors.lastname: Meyer
mesh_terms: D000069594:Abatacept; D000328:Adult; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D017277:Drug Approval; D006084:Graft Rejection / Q000188:drug therapy*; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D018796:Immunoconjugates; D007166:Immunosuppressive Agents; D000069594:Abatacept