Posted by jrbecker on August 13, 2004, at 9:21:34
Associated Press
Lilly Gets OK to Sell Yentreve in Europe
Friday August 13, 7:22 am ETLilly Gets OK to Sell Yentreve Female Incontinence Drug in Europe
INDIANAPOLIS (AP) -- Pharmaceutical companies Eli Lilly and Co. and Boehringer Ingelheim said Friday that they received European Union clearance to market their Yentreve treatment for moderate to severe stress urinary incontinence in women.
Stress urinary incontinence, or SUI, is the accidental leakage of urine during physical activities such as sneezing, coughing, laughing, lifting or exercising, and it affects nearly 15 million American adult women. The primary causes of SUI are weakness of the urethral sphincter or diminished pelvic support of the bladder and urethra. Risk factors include obesity, childbirth, chronic coughing and constipation.Yentreve is believed to affect SUI by blocking the reuptake of serotonin and norepinephrine in the spinal cord, and the increase in the neurotransmitters stimulates increased activity of the nerve that controls the urethral sphincter. This stimulation is believed to increase contraction of the external urethral sphincter, thereby helping prevent accidental urine leakage with physical activity.
Yentreve is currently being evaluated by the Food and Drug Administration for the treatment of SUI. The FDA issued an approvable letter for Yentreve in August 2003. Lilly and Boehringer Ingelheim recently submitted a complete response to the FDA's letter and anticipate approval from the agency in the first half of 2005.
"The proven reduction of incontinence episodes demonstrated in clinical studies and the statistically significant improvement in quality of life shown in women treated with Yentreve make this new oral medication an effective and well-tolerated treatment option for the many women living with SUI," said Manfred Haehl, corporate medical director for Boehringer Ingelheim.
In November 2002, Eli Lilly and Boehringer Ingelheim signed a global long-term agreement to jointly develop and commercialize duloxetine hydrochloride for the treatment of stress urinary incontinence, depression and diabetic neuropathic pain. In the United States, the partnership focuses on SUI.
Shares of Eli Lilly closed Thursday down 54 cents, or nearly 1 percent, at $62.06 on the New York Stock Exchange.
http://biz.yahoo.com/ap/040813/eli_lilly_yentreve_1.html
http://www.biospace.com/news_story.cfm?StoryID=17090320&full=1
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