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news.Merck has reported that its division Merck Serono received marketing authorization by the European Commission for Cyanokit for the treatment of known or suspected cyanide poisoning in both adults and children.
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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.
The unique mechanism of action of Cyanokit is based on its ability to tightly bind cyanide ions. Cyanokit is to be administered in conjunction with appropriate decontamination and supportive measures and may be used in a hospital setting or on-site at an emergency situation.
Cyanokit is the first cyanide antidote that is approved via the European centralized procedure. Cyanokit is reported to be the only cyanide antidote approved in the EU, US and Japan.
Roberto Gradnik, head of European operations at Merck Serono, said: “The European approval of Cyanokit is a key milestone for emergency healthcare professionals. We expect the availability of Cyanokit throughout Europe will have an impact on the survival and prevention of irreversible neurological injury of those who are poisoned by cyanide.”