European positive for Cymbalta and Xeristar

Sep 20 2004

Eli Lilly and Company and Boehringer Ingelheim have announced that the Committee for Medicinal Products in Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of duloxetine for the treatment of major depressive episodes.

The CHMP has recommended that the European Commission authorize the drug to be marketed. If approved, this pharmaceutical treatment for depression will be marketed throughout the European Union by Lilly under the brand name Cymbalta and by Boehringer Ingelheim under the brand names Cymbalta and in Greece, Italy and Spain, as Xeristar.

The European Commission is expected to grant marketing authorization within the next few months. Duloxetine was recently approved by the U.S. Food and Drug Administration and launched in the United States.

The CHMP, comprised of regulators from the European Union countries, based its positive opinion on its review of a comprehensive data package of duloxetine in the treatment of major depressive episodes. The submission package to support the efficacy and safety of duloxetine consisted of data collected from studies that enrolled nearly 3,000 patients with depression.

The European Medicines Agency issued a press release communicating the following: "The benefits with Cymbalta are its demonstrated statistical superiority over placebo as measured by improvement in the 17-item Hamilton Depression Rating Scale (HAM-D) total score (including both the emotional and somatic symptoms of depression). ...The CHMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit to risk balance for Cymbalta and therefore recommends the granting of the marketing authorisation."

Duloxetine is also being studied for the treatment of stress urinary incontinence and diabetic neuropathic pain, conditions believed to respond to treatment with medicines that affect the neurotransmitters serotonin and norepinephrine. On August 11, 2004 the European Commission granted marketing authorization throughout the European Union for duloxetine, to be marketed under the brand names, Yentreve.