Stress Urinary Incontinence Update

FDA requests further data before approval of Eli Lilly's duloxetine

Eli Lilly and Company [LLY] has received an approvable letter from the FDA's division of reproductive and urologic drug products for duloxetine for the treatment of stress urinary incontinence. Final FDA approval is contingent upon successful completion of additional acute preclinical and clinical pharmacology studies.

Satisfactory resolution of manufacturing issues at Lilly's Indianapolis manufacturing facilities, including the completion of a pre-approval site inspection; and completion of label negotiations will be factors in the FDA approval process. Lilly plans to conduct discussions with the FDA concerning the company's plans to provide the information the agency has requested. The results of these discussions will allow the company to provide a better estimate of the potential US approval date. Currently, pending more precise information, Lilly anticipates a US approval of duloxetine for SUI in late 2004 or the first half of 2005.

Duloxetine for depression, known as Cymbalta, is also currently under review by the FDA's division of neuropharmacologic drug products. Lilly received an approvable letter from the FDA for Cymbalta in September 2002.

"We are committed to bringing our innovative late stage products as quickly as possible to the patients who need them, to that end, we will work rapidly to provide the additional data requested by the agency and to resolve our outstanding manufacturing issues." said Sidney Taurel, chairman, president and CEO, Eli Lilly and Company, in a media release.

In November 2002, Lilly and Boehringer Ingelheim signed a long-term agreement to jointly develop and commercialize Duloxetine hydrochloride.

Duloxetine is currently being developed for the treatment of stress urinary incontinence (SUI) and depression. This partnership covers most countries worldwide with few exceptions. In the US, the collaboration is for SUI only.