EU Approval For Cymbalta In Generalised Anxiety Disorder

Main Category: Anxiety / Stress
Also Included In: Psychology / Psychiatry;  Regulatory Affairs / Drug Approvals;  Mental Health
Article Date: 24 Aug 2008 - 1:00 PDT

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The European Commission has approved the use of Cymbalta (duloxetine) in treating generalised anxiety disorder (GAD), paving the way for the drug to be launched in all 27 member-states of the European Union. The verdict will also allow Cymbalta to be marketed in Iceland, Liechtenstein and Norway. Jointly produced by Eli Lilly (U.S.) and Boehringer Ingelheim (Germany), Cymbalta is already approved for treating GAD in the United States and Mexico.

GAD is characterised by excessive and chronic levels of anxiety, with often uncontrollable worrying about events that does not dissipate once the events have passed. Irritability and poor concentration are also symptoms of the condition. According to Eli Lilly, there are over 9 million people with GAD in Europe, offering a sizeable potential patient population. Cymbalta is already approved for several indications in Europe - including major depressive disorder and diabetic peripheral neuropathic pain - which makes its approval following a recommendation from the European Medicine Agency (EMEA) unsurprising.

Only a handful of top-selling treatments are approved for treating various forms of anxiety, but within these, Cymbalta's biggest competitor in Europe will be GAD drug Cipralex (escitalopram), produced by Danish drug-maker Lundbeck. Cipralex's global sales grew by 17% year-on-year (y/y) and reached US$752.6 in 2007, while Eli Lilly's sales of Cymbalta soared by 60% y/y to stand at US$2.1 billion.

Outlook and Implications

Eli Lilly's success in approving Cymbalta for GAD now brings the drug's European treatment areas to four, completing its cycle of possible indications in the region. Both partners have invested heavily in demonstrating Cymbalta's effectiveness across a wide variety of indications in order to extract maximum sales value from the blockbuster, allowing it to replace older drugs such as Zyprexa (olanzapine) in Lilly's pipeline. This effort to maximise a drug's approved indications is increasingly the preferred approach of most producers of blockbuster treatments as they look for new ways to ward off generic competition.

While the European Commission's approval of Cymbalta for GAD is obviously good news for Eli Lilly and Boehringer Ingelheim, the two firms will now face a much greater challenge in seeking reimbursement status for the drug in individual European markets. At a time of increased cost-consciousness in healthcare, national drug watchdogs may be reluctant to approve public funding for Cymbalta in this particular indication. In the United Kingdom, for instance, physicians are increasingly prioritising the use of cognitive therapy to help relieve the symptoms of GAD, avoiding medication unless absolutely necessary. This does not necessarily imply that Cymbalta's use in GAD will be refused reimbursement in the U.K. or elsewhere in Europe, but could suggest that national reimbursement agencies may be inclined to restrict the drug's recommended reimbursement status to second-line use. Questions will also be raised as to Cymbalta's therapeutic advantages over Cipralex in GAD, and some national drugs agencies could recommend head-to-head studies before reimbursement status is granted.

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Source - Catarina Walsh
www.globalinsight.com