Eli Lilly and Co and Boehringer Ingelheim have announced that the European Commission has approved the use of Cymbalta (duloxetine) for the treatment of (GAD). This approval the fourth for duloxetine in Europe was issued on 28 July following an initial positive opinion issued by the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) on 26 June 2008.

The approval is based upon the results of five clinical studies of GAD four doubleblind shortterm (acute) placebocontrolled studies and a placebocontrolled relapse prevention study involving more than 2,000 nondepressed adults with GAD.

Although global prevalence is not currently known, more than nine million Europeans and six million people in Central and South America are estimated to suffer from GAD, which is characterised by excessive anxiety and worry about a number of events and activities (such as performance at work or school) over a sustained period of at least six months.

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.

Cymbalta, a member of a class of drugs commonly referred to as serotonin and noradrenaline reuptake inhibitors, is already approved by the EMEA to treat major depressive disorder and diabetic peripheral neuropathic pain. Duloxetine gained marketing authorisation for the treatment of GAD in Mexico in 2006 and in the United States in 2007.

Quality of life is affected as symptoms of GAD can include exaggerated worry or chronic anxiety, irritability and poor concentration. Ability to work is often compromised with the manifestation of physical symptoms such as muscle tension, fatigue, sleep disturbance and nausea. The illness tends to be chronic with periods of exacerbation and remission. Patients report that episodes of GAD are often brought on, or worsened, by stressful life events.

While duloxetine's mechanism of action in humans is not fully known, it is believed to affect both serotonin and norepinephrine/noradrenalinemediated nerve signalling in the brain and the spinal cord.

Lilly, a leading innovationdriven corporation, is developing a growing portfolio of bestinclass pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and almost 38,900 employees.