Cymbalta gets GAD Approval in the EU

Eli Lilly and Co and Boehringer Ingelheim have announced that Cymbalta has been given approval in the EU for use as a treatment for Generalised Anxiety Disorder (GAD).

Cymbalta (duloxetine) was the second drug to be approved, earlier this year, by the American Food & Drug Administration (FDA) as a treatment for the management of Fibromyalgia Syndrome (Fibro). It is also approved in the US for the treatment of Major Depressive Disorder, Generalised Anxiety Disorder (for which it received approval in 2007) and Diabetic Nerve Pain.

Cymbalta is already approved by the European Medicines Agency (EMEA) to treat Major Depressive Disorder and Diabetic Peripheral Neuropathic Pain.

It is likely Cymbalta will be approved for use in managing Fibro in the EU at some point in the next couple of years.

The two pharmaceutical firms, Eli Lilly & Co and Boehringer Ingelheim, signed a long-term agreement in November 2002 to jointly develop and commercialize duloxetine hydrochloride, which is marketed as Cymbalta by Eli Lilly.