Chelsea's droxidopa gets two OD designations in EU

The USA's Chelsea Therapeutics says that its drug candidate droxidopa, a synthetic amino acid, has been granted two Orphan Medicinal Product designations by the European Commission for the treatment of orthostatic hypotension in patients with pure autonomic failure and patients with multiple systems atrophy. These designations are based on a recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency (EMEA) and follow the previously-announced Orphan Drug designation granted by the US Food and Drug Administration in January 2007.

Simon Pedder, chief executive of Chelsea, said: "the 10-year exclusivity afforded by these designations combined with the 10-year [New Chemical Entity] exclusivity for the treatment of OH in Parkinson's disease in the [European Union] complement our existing US orphan designation and firmly establishes global exclusivity for droxidopa."