Pharmaceutical Business review

Merck Serono gets European approval for Cyanokit 5g

Cyanokit is currently made available in a kit comprising two 2.5g vials as the starting dose that totals 5g hydroxocobalamin, while the new presentation contains the starting dose of 5g hydroxocobalamin in a single vial.

Cyanokit is typically administered by fire and rescue crews at an emergency scene or in a hospital emergency room.

Merck Serono Research and Development executive vice president Bernhard Kirschbaum said that immediate administration of an emergency treatment on the scene of a fire within the first minutes after rescue is critical for the survival of a smoke inhalation victim.

"By simplifying the reconstitution and administration processes, we believe that the new Cyanokit 5g presentation represents a major improvement, allowing for rapid management of cyanide poisoning," Kirschbaum said.

Merck Serono markets Cyanokit in Europe with the exception of the Netherlands, Ireland, the UK and the Nordic and Baltic countries where it is marketed by its partner Swedish Orphan Biovitrum.

Merck Serono said that the supplemental new drug application (sNDA) in US for the new Cyanokit presentation is currently under review by the US Food and Drug Administration.