Drug withdrawal sends critical care specialists back to basics

Xigris, also known as activated protein C, took offto a bright start in 2000 when the phase 3 PROWESS trial was stopped early because of the drug's high efficacy (reducing the relative risk of death by 20% compared with placebo). Centocor's Centoxin, an endotoxin-targeting monoclonal antib...

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Bibliographic Details
Published in:The Lancet (British edition) 2011-11, Vol.378 (9805), p.1769-1769
Main Author: Mullard, Asher
Format: Article
Language:eng
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Summary:Xigris, also known as activated protein C, took offto a bright start in 2000 when the phase 3 PROWESS trial was stopped early because of the drug's high efficacy (reducing the relative risk of death by 20% compared with placebo). Centocor's Centoxin, an endotoxin-targeting monoclonal antibody, was marketed in Europe in 1992 for severe sepsis on the basis of a single trial but was withdrawn when a second trial to support FDA approval raised safety flags.
ISSN:0140-6736
1474-547X