Eli Lilly and Boehringer Ingelheim announced that Yentreve (duloxetine hydrochloride) has been granted marketing authorization across the European Union (EU) for the treatment of moderate to severe stress urinary incontinence (SUI) in women.
Lilly and Boehringer Ingelheim have recently submitted a complete response to the FDA and anticipate approval from the agency for Yentreve in the first half of 2005.
"With the EU approval of Yentreve, Lilly and Boehringer Ingelheim are excited to soon be offering patients in Europe the first medication indicated for the specific symptoms of SUI -a distressing and embarrassing medical disorder that affects millions of women worldwide," said Dr. Tim Garnett, group medical director, Eli Lilly and Company.
"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," Manfred Haehl, corporate medical director, Boehringer Ingelheim said adding, "We are very pleased that The European Agency for the Evaluation of Medicinal Products has acknowledged the importance of this novel medication, which we can now offer to SUI patients throughout Europe."
SUI is the accidental leakage of urine during physical activities such as sneezing, coughing, laughing, lifting or exercising. With nearly twice the prevalence as urge incontinence, SUI is the most common form of urinary incontinence among women.
The primary causes of SUI are weakness of the urethral sphincter and/or diminished pelvic support of the bladder and urethra. Risk factors include obesity, childbirth, chronic coughing and constipation.
Yentreve is a balanced dual reuptake inhibitor of the neurotransmitters serotonin and norepinephrine and is currently being evaluated by the US FDA for the treatment of SUI. The FDA issued an approvable letter for Yentreve in August 2003.
Yentreve is believed to affect SUI by blocking the reuptake of serotonin and norepinephrine in the spinal cord, and the increase in the neurotransmitters in turn stimulates increased activity of the pudendal nerve that controls the external urethral sphincter. This stimulation is believed to increase contraction of the external urethral sphincter, thereby helping prevent accidental urine leakage with physical activity.