Merck Serono confirms EU approval for Cyanokit

Merck Serono, a division of Merck KGaA, has confirmed that its product Cyanokit has been granted marketing authorisation by the European commission.

The European Union approved Cyanokit’s marketing licence for the treatment of known or suspected cyanide poisoning in both adults and the paediatric population.

Roberto Gradnik, head of Merck Serono’s European operations, described the decision as a “key milestone” for emergency healthcare professionals.

“They will now have a safe and effective product to treat people immediately for cyanide poisoning, either at the scene of a fire, accident or other emergency, or at the hospital.”

European marketing authorisation was based on a series of clinical trials supporting Cyanokit’s safety and efficacy profile, including data from three studies carried out in subjects who had been exposed to smoke inhalation from fires.

Cyanokit is now the first cyanide antidote approved in the European Union, the United States and Japan.

The product received approval from the US Food and Drug Administration in December 2006 and from the Japanese Health Authority in September 2007.

Also this week, Merck Serono and its partner Newron Pharmaceuticals initiated a new Phase III clinical trial investigating the use of Safinamide for Parkinson’s disease.