Anthrax drug first antibacterial mAb to win approval

Officials of the US Food and Drug Administration (FDA) in mid-December approved ABthrax, or raxibacumab, for use in patients with inhalational anthrax. This approval is the first under the agencys animal rule, established for evaluating the efficacy of products that would be unethical or impossible...

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Bibliographic Details
Published in:Nature biotechnology 2013-01, Vol.31 (1), p.8-8
Main Author: Fox, Jeffrey L
Format: Article
Language:English
Subjects:
631/154/2426/1599
631/61/338/22/1290
631/61/51
Agriculture
Anthrax
Anthrax - therapy
Antibiotics
Antibodies, Monoclonal - therapeutic use
Bacteria
Bioinformatics
Biological Warfare
Biomedical and Life Sciences
Biomedical Engineering/Biotechnology
Biomedicine
Biotechnology
Biotechnology industry
Drug Approval - legislation & jurisprudence
Drug Industry
Drug therapy
FDA approval
Humans
Licensing, certification and accreditation
Life Sciences
news
Raxibacumab
United States
United States Food and Drug Administration
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Summary:Officials of the US Food and Drug Administration (FDA) in mid-December approved ABthrax, or raxibacumab, for use in patients with inhalational anthrax. This approval is the first under the agencys animal rule, established for evaluating the efficacy of products that would be unethical or impossible to test (except for safety) in humans. ABthrax is a human monoclonal antibody (mAb), licensed for use as an adjunct to conventional antibiotics such asCipro (ciprofloxacin).
ISSN:1087-0156
1546-1696
DOI:10.1038/nbt0113-8