This approval – the fourth for duloxetine in Europe – was issued in July 2008, following an initial positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use in June 2008.
The approval is based upon the results of five clinical studies of generalized anxiety disorder (GAD) – four double-blind short-term (acute) placebo-controlled studies and a placebo-controlled relapse prevention study – involving more than 2,000 non-depressed adults with GAD.
This regulatory approval paves the way for launches in Europe and applies to all 27 countries of the European Union, as well as Norway, Iceland and Liechtenstein, said Eli Lilly.