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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Veröffentlicht in:	Nature biotechnology 2013-01, Vol.31 (1), p.8-8
1. Verfasser:	Fox, Jeffrey L
Format:	Artikel
Sprache:	eng
Schlagworte:	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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Beschreibung
Zusammenfassung:	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