Duloxetine Approved In EU For Stress Urinary Incontinence
This article was originally published in The Pink Sheet Daily
Executive Summary
Lilly and marketing partner Boehringer Ingelheim plan to launch duloxetine under the trade name Yentreve by year-end in the European Union. The NDA for Yentreve is pending at FDA.
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Lilly and Boehringer Ingelheim plan to launch Yentreve in the European Union by the end of the year. Yentreve (duloxetine) was granted market authorization Aug. 13 for "treatment of moderate to severe stress urinary incontinence in women." Lilly and marketing partner BI will jointly market Yentreve. Dosing for the selective serotonin and norepinephrine reuptake inhibitor is 40 mg twice daily. The most common adverse event associated with Yentreve is nausea. Other AEs reported by over 5% of patients include dry mouth, fatigue, insomnia, constipation, headache, dizziness, drowsiness and diarrhea. Lilly's application for Yentreve is pending at FDA, following an approvable letter in August 2003 requesting additional studies. The approval strategy for Yentreve to treat SUI and Lilly's other duloxetine product ( Cymbalta ) for major depressive disorder is reversed in the U.S. and European markets. Cymbalta cleared FDA Aug. 3 for treatment of major depressive disorder (1 (Also see "Cymbalta Approved; Lilly Antidepressant Will Be Available By Late August" - Pink Sheet, 4 Aug, 2004.)). Lilly expects Cymbalta to be approved in certain European countries in 2005. Lilly may request a third duloxetine brand name for a diabetic neuropathic pain indication currently under study. - Andrew Kasper |