Document Detail

The birth pangs of monoclonal antibody therapeutics: the failure and legacy of Centoxin.
MedLine Citation:
PMID:  22531443     Owner:  NLM     Status:  MEDLINE    
This paper examines the development and termination of nebacumab (Centoxin®), a human IgM monoclonal antibody (mAb) drug frequently cited as one of the notable failures of the early biopharmaceutical industry. The non-approval of Centoxin in the United States in 1992 generated major concerns at the time about the future viability of any mAb therapeutics. For Centocor, the biotechnology company that developed Centoxin, the drug posed formidable challenges in terms of safety, clinical efficacy, patient selection, the overall economic costs of health care, as well as financial backing. Indeed, Centocor's development of the drug brought it to the brink of bankruptcy. This article shows how many of the experiences learned with Centoxin paved the way for the current successes in therapeutic mAb development.
Lara Marks
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Review     Date:  2012-04-26
Journal Detail:
Title:  mAbs     Volume:  4     ISSN:  1942-0870     ISO Abbreviation:  MAbs     Publication Date:    2012 May-Jun
Date Detail:
Created Date:  2012-09-10     Completed Date:  2013-02-06     Revised Date:  2013-06-25    
Medline Journal Info:
Nlm Unique ID:  101479829     Medline TA:  MAbs     Country:  United States    
Other Details:
Languages:  eng     Pagination:  403-12     Citation Subset:  IM    
Department of Primary Care and Public Health, King's College London, London, UK.
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MeSH Terms
Antibodies, Monoclonal / therapeutic use*
Biopharmaceutics / trends
Costs and Cost Analysis
Drug Approval
Drug Discovery*
Product Recalls and Withdrawals
Sepsis / immunology,  therapy*
United States
Reg. No./Substance:
0/Antibodies, Monoclonal; 138330-99-1/nebacumab

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

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