EMEA approves Cymbalta for GAD

The European Commission has approved the use of US drug major Eli Lilly and Germany's Boehringer Ingelheim's Cymbalta (duloxetine) for generalized anxiety disorder.

This approval, the fourth for duloxetine in Europe was issued on July 28 following an initial positive opinion issued by the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) on June 26. Cymbalta was Lilly's second-highest earner last year, with sales of $2.1 billion.

The approval is based upon the results of five clinical studies of 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.