Orion announced today that the EU marketing authorisation application for dexmedetomidine, a sedative for use in the intensive care setting, has been withdrawn from the EMEA (European Agency for the Evaluation of Medicinal Products) review process. The CPMP (Committee for Proprietary Medicinal Products) of the EMEA has requested additional clinical data from studies comparing dexmedetomidine with current therapies. The EU application has been under review by the EMEA since late 1998. Dexmedetomidine received U.S. marketing approval in December 1999.
Specifically, the CPMP requested additional clinical data to better assess the risk/benefit profile of dexmedetomidine relative to other agents used in the ICU. Studies to date have examined dexmedetomidine in comparison to placebo.
Dexmedetomidine is a pharmaceutical compound discovered by Orion Pharma and it was licensed to Abbott Laboratories in 1994. Abbott is responsible for the global development, registration and marketing of dexmedetomidine.
Abbott Laboratories remains committed to the development of dexmedetomidine for use in Europe and will work with regulatory authorities to adequately answer outstanding questions.
In addition to the US, dexmedetomidine has also been approved in Peru, and applications in several countries are pending.