Visanne® cleared for market launch in Europe as new treatment option for endometriosis
Bayer Schering Pharma AG, Germany, has successfully completed the decentralized part of drug approval procedure in Europe for a new treatment of endometriosis called Visanne®. Visanne is a once-daily oral tablet containing dienogest 2 mg that has been developed specifically for the treatment of endometriosis. A dedicated clinical study programme has proven that Visanne relieves endometriosis pain with high efficacy, reduces endometriosis lesions and demonstrates a favourable safety and tolerability profile. Market launch of the product is planned from the second quarter 2010 onwards.
"With Visanne, we will be able to offer women a new treatment option which
can reduce the substantial burden of endometriosis," said Phil Smits, MD,
Head of Bayer Schering Pharma’s Business Unit Women’s Healthcare. "Surgical
treatment of endometrosis is associated with high relapse rates and many
currently available medical therapy options have side effects which do not
allow for long-term use. Patients often need to use different combinations
of the available treatment options and even undergo repeat surgical
procedures.There is therefore a high medical need for new treatment
options."
The current standard therapy (regarding efficacy), GnRH analogue, can only
be used for the short-term relief of symptoms associated with
endometriosis, as safety concerns such as decreased bone mineral density
and side effects such as hot flushes limit its long-term use. Visanne has
been shown to be as effective as GnRH analogue and to be superior to
placebo in reducing pain related to endometriosis. Pain relief is sustained
over time (shown in a clinical study lasting 15 months) and includes
dysmenorrhea-like pain, pre-menstrual pain, diffuse pelvic pain and
dyspareunia.
About Endometriosis
Endometriosis is a chronic gynecological disease defined by presence of
endometrium-like tissue outside the uterus, which induces a chronic,
inflammatory reaction. The endometrium is a layer of mucous tissue, which
lines the uterus cavity and undergoes hormone-dependent changes during the
menstrual cycle. Endometriosis is a common disease among women of
reproductive age. The prevalence is estimated to be around 5-10% in women
of childbearing age. Lower abdominal and pelvic pain, cramping menstrual
pains (dysmenorrhea), painful sexual intercourse (dyspareunia) and
infertility are well recognized symptoms of endometriosis.
About Bayer The Bayer Group is a global enterprise with core competencies in the fields
of health care, nutrition and high-tech materials. Bayer HealthCare, a
subsidiary of Bayer AG, is one of the world's leading, innovative companies
in the healthcare and medical products industry and is based in Leverkusen,
Germany. The company combines the global activities of the Animal Health,
Consumer Care, Diabetes Care and Pharmaceuticals divisions. The
pharmaceuticals business operates under the name Bayer Schering Pharma AG.
Bayer HealthCare's aim is to discover and manufacture products that will
improve human and animal health worldwide. Find more information at
http://www.bayerhealthcare.com.About Bayer Schering Pharma Bayer Schering Pharma is a worldwide leading specialty pharmaceutical
company. Its research and business activities are focused on the following
areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's
Healthcare. With innovative products, Bayer Schering Pharma aims for
leading positions in specialized markets worldwide. Using new ideas, Bayer
Schering Pharma aims to make a contribution to medical progress and strives
to improve the quality of life. Find more information at
http://www.bayerscheringpharma.de.