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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Published in: | The Lancet (British edition) 2011-11, Vol.378 (9805), p.1769-1769 |
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Main Author: | |
Format: | Article |
Language: | eng |
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Online Access: | Get full text |
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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monoclonal antibody, was marketed in Europe in 1992 for severe sepsis on the basis of a single trial but was withdrawn when a second trial to support FDA approval raised safety flags. |
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ISSN: | 0140-6736 1474-547X |