Yentreve(reg)/Ariclaim(reg) approved in Europe for the treatment of Stress Urinary Incontinence in women

Main Category: Urology / Nephrology
Article Date: 13 Aug 2004 - 11:00 PDT

email to a friend   printer friendly   view / write opinions

Eli Lilly and Company and Boehringer Ingelheim announced today that Yentreve(reg)/ Ariclaim(reg) (duloxetine hydrochloride) have been granted marketing authorization throughout the European Union (EU) by the European Commission for the treatment of moderate to severe stress urinary incontinence (SUI) in women.

Worldwide, one in seven women over the age of 20 have SUI.1 The most common form of urinary incontinence, SUI is the accidental leakage of urine due to physical activities such as sneezing, coughing, lifting, or exercising2 SUI has a significant impact on quality of life, leaving many women unable to enjoy daily activities, such as laughing or picking up a child.3 Yentreve(reg)/ Ariclaim(reg), the first pharmaceutical widely approved to treat SUI, will help women reduce the number of leakages they experience, and improve their quality of life.4

"The approval of Yentreve(reg)/ Ariclaim(reg) is very welcome as to date there have been no drugs specifically developed and approved for use in women with stress urinary incontinence," said Professor Linda Cardozo, Professor of Urogynaecology at King`s College Hospital, London, UK. "Many women fail to comply with pelvic floor exercises, especially in the longer term, and are unwilling to undergo surgery for a variety of reasons. For them, and for the clinicians who see such women, Yentreve(reg)/ Ariclaim(reg) will help to bridge the treatment gap by increasing the available therapeutic options and hopefully improving the quality of life of many women."

Ten studies involving more than 2,000 women with SUI across five continents have demonstrated that Yentreve(reg)/ Ariclaim(reg) - a balanced dual reuptake inhibitor of the neurotransmitters serotonin and norepinephrine5- effectively reduces the frequency of incontinence episodes by up to 53%4 and is generally well tolerated with mild to moderate and manageable side effects, the most common of which is transient nausea.6

"With the EU approval of Yentreve(reg)/ Ariclaim(reg), Lilly and Boehringer Ingelheim are excited to soon be offering patients the first and only widely approved medication specifically indicated for the treatment of SUI - a distressing and embarrassing medical condition 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(reg)/ Ariclaim(reg), make this new oral medication an efficient and well tolerated treatment option for the millions of women living with stress urinary incontinence", said Manfred Haehl, M.D., Corporate Medical Director, Boehringer Ingelheim. "We are very pleased that the European regulatory agency has acknowledged the importance of this novel medication which we can now offer to SUI patients throughout Europe."

This pharmaceutical treatment for SUI will be jointly co-promoted throughout the European Union by Lilly and Boehringer Ingelheim under the brand name Yentreve(reg) except for Greece, Italy, and Spain, where it will be marketed under the brand name Yentreve(reg) by Lilly and Ariclaim(reg) by Boehringer Ingelheim.

Yentreve(reg)/Ariclaim(reg) for the Treatment of SUI

Studies show that Yentreve(reg)/ Ariclaim(reg) is a balanced dual reuptake inhibitor of the neurotransmitters serotonin and norepinephrine,5 neurotransmitters which are believed to play key roles in the normal closure of the urethral sphincter, the muscle that - if weakened - can cause SUI.5,7 By increasing neurotransmitter concentration, Yentreve(reg)/ Ariclaim(reg) is believed to increase the tone and contraction of the urethral sphincter, which helps prevent accidental urine leakage due to physical activities such as sneezing, coughing, laughing, lifting or exercising.

Stress Urinary Incontinence

With nearly twice the prevalence as urge incontinence, SUI is the most common form of urinary incontinence in women. Although common, SUI is a medical condition that is not normal at any age and causes embarrassment and even social isolation, which may have a profound negative impact on the quality of life of the affected individuals.

Even though many women are bothered by their symptoms of SUI, they often do not seek appropriate medical attention because they are embarrassed or they believe it is a normal part of aging.

Several risk factors or contributing variables to the development of SUI have been suggested over the last decade and include childbirth, obesity, pelvic organ prolapse or chronic coughing.8 Presently available treatment options include behavioral therapy, pelvic floor muscle training and surgery.

Eli Lilly and Company and Boehringer Ingelheim

In November 2002, Eli Lilly and Company 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 USA, the collaboration excludes neuroscience indications.

The Yentreve(reg)/Ariclaim(reg) clinical research program is striving to improve the lives of millions of women worldwide who suffer from SUI. It is a long-term, extensive and evolving global initiative, sponsored by Eli Lilly and Company and Boehringer Ingelheim, and is designed to investigate SUI, its impact on women's quality of life, and the efficacy and safety of Yentreve(reg)/ Ariclaim(reg) in a wide range of patients and clinical settings.

Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world`s most urgent medical needs.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 152 affiliates in 45 countries and more than 34,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2003, Boehringer Ingelheim posted net sales of 7.4 billion euro while spending more than one fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

This press release contains forward-looking statements about the potential of duloxetine for the treatment of stress urinary incontinence and reflects Lilly`s and Boehringer Ingelheim's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of commercialization.

Contact:

Boehringer Ingelheim GmbH
Corporate Division Communications
Judith von Gordon
55216 Ingelheim am Rhein
GERMANY
Phone: +49/6132/77 35 82
Fax: +49/6132/77 66 01

Eli Lilly and Company
Christine Van Marter
PO Box 23456 Indianapolis, Indiana
USA
Phone: (1)317-655-2249

References:

1. Calculated estimate: (Female UI prevalence: 35%)i; (UI subtype prevalence: 49% SUI; 29% SUI + UUI: 22% UUI) ii; (Severe or bothersome rates: 17%-24% SUI; 38%-47% SUI + UUI; 28%-36% UUI)iii; (1998 Population Estimates: US Bureau of the Census, Report WP/98 = 307 million female SUI sufferers worldwide) iv: i/ii Hampel C, et al. Prevalence and natural history of female incontinence. Eur Urol. 1997;32 Suppl 2:3-12; iii Haanestad et al 2000; iv 1998 Population Estimates: US Bureau of the Census, Report WP/98

2. Abrams P, Cardozo L, Fall M, Griffiths, D, Rosier P, Ulmsten U et al. The standardisation of terminology of lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Neurourol Urodyn 2002;21(2):167-78.

3. Fultz NH et al. Burden of stress urinary incontinence for community-dwelling women. Am J Obstet Gynecol. 2003; November: 1275-1282.

4. Bump R et al. Duloxetine for SUI: Meta-analysis of Worldwide Efficacy. Abstract presented at the Congress of the Society of Urodynamics and Female Urology (SUFU), Chicago, USA. April 2003.

5. Bymaster FP, Dreshfield-Ahmad LJ, Threlkeld PG et al. Comparative Affinity of Duloxetine and Venlafaxine for Serotonin and Norepinephrine Transporters in vitro and in vivo, Human Serotonin Receptor Subtypes, and Other Neuronal Receptors. Neuropsychopharmacology 2001: 25(6):871-80.

6. Hurley, Baygani, Simmons, Yalcin, Bump R. Duloxetine for Stress Urinary Incontinence: A Meta-Analysis of Safety. Abstract presented at the 33rd Annual Meeting of the International Continence Society (ICS), Florence, Italy. 5-9 October 2003.

7. Hurley, Baygani, Simmons, Yalcin, and Bump. Duloxetine for Stress Urinary Incontinence (SUI): Meta-Analysis of Safety. Abstract presented at the International Federation of Gynecology and Obstetrics (FIGO) World Congress, Santiago, Chile. 2-7 November 2003.

8. Viktrup L. Female stress and urge incontinence in family practice: insight into the lower urinary tract. Int J Clin Prac 2002;56(9):694-700.