Eli Lilly took a knocking on Friday after the company and German partner, Boehringer Ingelheim, said that they had withdrawn the US marketing application for the stress urinary incontinence drug, Cymbalta (duloxetine), because regulators had said they could not approve the product based on the data package submitted.
The companies say they will evaluate all options for next steps once they have had time to fully understand the Food and Drug Administration’s perspective. The firms also say that ongoing clinical trials for the product in the treatment of SUI will continue.
Cymbalta is already approved in Europe for treating major depressive episodes - and SUI under the brand name of Yentreve [[13/09/04e]] - [[05/01/05b]], [[13/08/04a]], and is also approved to treat major depression and peripheral neuropathy in the USA [[05/08/04b]]. However, its route to market in the US was far from smooth. Having won an approvable letter back in 2002, the FDA said that the company would first have to resolve the manufacturing issues that had dogged its Indianapolis facilities before being granted the final nod [[17/09/02a]]. The agency then extended its deadline for deciding whether to clear the product by three months, to give itself more time to review paediatric data at a time when the safety of certain antidepressants in this population was under heightened scrutiny [[25/06/04c]].
“Despite this decision, we continue to have confidence in duloxetine, which is currently available for the treatment of stress urinary incontinence in many other countries,” said Sidney Taurel, Lilly’s chairman, president and chief executive officer. “We are certainly disappointed with this outcome but are committed to exploring our options for duloxetine, as millions of American women who suffer from SUI do not currently have a pharmaceutical option to help manage their condition,” stated Dr Alessandro Banchi, chairman of BI’s board of directors.