European Medicines Agency Approves Duloxetine for Depression Treatment

Strategic Insights -

The European Medicines Agency's Committee for Medicinal Products in Human Use (CHMP) has issued a positive opinion recommending approval of duloxetine for the treatment of major depressive episodes. This decision is a significant milestone in the development and marketing of duloxetine, which is expected to be authorized for marketing in the European Union within the next few months. Duloxetine, to be marketed under the brand name Cymbalta by Eli Lilly and Co. and Boehringer Ingelheim, has already been approved by the U.S. Food and Drug Administration and launched in the United States.

Key Takeaways:

  • The CHMP based its positive opinion on a comprehensive data package of duloxetine in the treatment of major depressive episodes, which consisted of data collected from studies that enrolled nearly 3000 patients with depression.
  • Duloxetine has demonstrated statistical superiority over placebo as measured by improvement in the 17-item Hamilton Depression Rating Scale total score, including both emotional and somatic symptoms of depression.
  • The CHMP considers that there is a favorable benefit-to-risk balance for Cymbalta and recommends the granting of marketing authorization.
  • Eli Lilly and Co. and Boehringer Ingelheim will market duloxetine throughout the European Union as Cymbalta, with Boehringer Ingelheim also marketing it in Greece, Italy, and Spain as Xeristar.
  • 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.

Statistics:

  • Nearly 3000 patients with depression were involved in studies to support the efficacy and safety of duloxetine.
  • Duloxetine has demonstrated statistical superiority over placebo in improving the 17-item Hamilton Depression Rating Scale total score.
  • The European Commission granted marketing authorization throughout the European Union for duloxetine to be marketed under the brand name Yentreve on August 11, 2004.

Sources:

  • Eli Lilly and Co.
  • Boehringer Ingelheim
  • European Medicines Agency (EMA)
  • U.S. Food and Drug Administration (FDA)
  • Biotech Business Week via NewsRx.com & NewsRx.net