Document Detail


Summary of the US FDA approval of belatacept.
MedLine Citation:
PMID:  22335273     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
P Archdeacon; C Dixon; O Belen; R Albrecht; J Meyer
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Publication Detail:
Type:  Journal Article     Date:  2012-02-15
Journal Detail:
Title:  American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons     Volume:  12     ISSN:  1600-6143     ISO Abbreviation:  Am. J. Transplant.     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-02-29     Completed Date:  2012-06-21     Revised Date:  2013-05-24    
Medline Journal Info:
Nlm Unique ID:  100968638     Medline TA:  Am J Transplant     Country:  United States    
Other Details:
Languages:  eng     Pagination:  554-62     Citation Subset:  IM    
Copyright Information:
© copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons.
Affiliation:
Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
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MeSH Terms
Descriptor/Qualifier:
Adult
Consumer Product Safety / legislation & jurisprudence*
Drug Approval*
Graft Rejection / drug therapy*
Humans
Immunoconjugates / therapeutic use*
Immunosuppressive Agents / therapeutic use*
Kidney Transplantation*
United States
United States Food and Drug Administration
Chemical
Reg. No./Substance:
0/Immunoconjugates; 0/Immunosuppressive Agents; 7D0YB67S97/abatacept
Comments/Corrections
Comment In:
Am J Transplant. 2012 Mar;12(3):513-4   [PMID:  22335245 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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