To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Merck KGaA's Cyanokit Approved in the European Union URL: http://www.pslgroup.com/dg/218276.htm Doctor's Guide November 29, 2007
European Commission grants marketing authorization for Cyanokit for the treatment of known or suspected cyanide poisoning DARMSTADT, GERMANY -- November 29, 2007 -- Merck KGaA announced today, its division Merck Serono has been granted marketing authorization by the European Commission for its product Cyanokit (hydroxocobalamin) for the treatment of known or suspected cyanide poisoning in both adults and the pediatric population. Cyanokit is the first cyanide antidote that is approved via the European Centralized Procedure. Cyanokit is the only cyanide antidote approved in the European Union, the United States of America and Japan. The unique mechanism of action of Cyanokit is based on its ability to tightly bind cyanide ions. It may be used in a hospital setting or on-site at an emergency situation. Cyanokit is to be administered in conjunction with appropriate decontamination and supportive measures. Cyanide poisoning is primarily caused by smoke inhalation during closed-space structural fires. Additional causes may include accidental or intentional ingestion, inhalation, dermal exposure during industrial accidents or a terrorist attack involving cyanide. The European marketing authorization of Cyanokit is supported by safety data in healthy adults and efficacy data in adults and pediatrics, including data from three studies carried out in subjects who had been exposed to smoke inhalation from fires. Due to ethical considerations, no controlled human efficacy studies have been performed. Four uncontrolled clinical studies were conducted in known or suspected cyanide-poisoning victims. A total of 245 patients were included in these studies evaluating the efficacy of Cyanokit as an antidote. Of the 213 patients in whom the outcome was known, the survival was 58%. Of the 89 patients who died, 63 were initially found in cardiac arrest, suggesting that many of these patients had almost certainly suffered irreparable brain injury prior to administration of Cyanokit. Among the 144 patients not in initial cardiac arrest whose outcomes were known, 118 (82%) survived. Furthermore, in 34 patients with known cyanide concentrations above the lethal threshold (≥100 mumol/l), 21 (62%) survived following treatment with Cyanokit. Where neurological assessment over time was possible, (96 of the 171 patients who presented with neurological symptoms prior to Cyanokit administration), 51 (53%) patients receiving Cyanokit showed improvement or a complete restoration. The most common side effects associated with Cyanokit are red coloration of the skin, mucous membranes and urine, all of which are reversible. "Clinical data show that Cyanokit is very effective in treating cyanide poisoning, even in patients with extremely toxic levels of cyanide in their bodies, as well as in complex clinical settings including smoke inhalation in which the presence of cyanide is always presumptive," said FrÚdÚric Baud, MD, Professor of Critical Care Medicine at LariboisiÞre hospital, Paris University VII. "The favorable safety profile of Cyanokit is very important in an emergency situation requiring rapid, life-saving treatment," added Dr Jean-Luc Fortin, MD, former Chief Medical Officer at the Paris fire brigade. Cyanokit received approval from the US Food and Drug Administration in December 2006 and from the Japanese Health Authority in September 2007. SOURCE: Merck KGaA --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.