Bayer Schering Pharma AG, Germany, has submitted Visanne for the treatment of endometriosis for registration to all Member States of the European Community. The Netherlands will serve as the Reference Member State for the Decentralized Procedure to receive European-wide Marketing Authorization. Visanne contains 2 mg of Dienogest and is administered orally once a day. In contrast to other drugs used for the treatment of this chronic gynaecological disease, Visanne is an endometriosis-specific therapy for the long-term treatment of endometriosis. The current standard-therapy with GnRH analogue is only suitable for short-term treatment due to severe side-effects.
"We focus on gynaecological markets with significant growth potential where we aim for global leadership. With the submission of Visanne we have reached another important strategic milestone in the development of innovative gynaecological products geared towards improving women's health," said Phil Smits, head of Bayer Schering PharmaZs business unit Women's Healthcare. "As endometriosis is a long-lasting gynaecological condition that causes dramatic and recurrent pain, turning a woman's life upside down, there is a need for an effective and well tolerated treatment that can be used over a long period of time. Visanne adresses this need with an endometriosis-specific therapy that has the same efficacy as the current therapeutic standard but with significantly less side effects, thus allowing for long-term treatment," said Smits.
The standard therapy GnRH analogue is only effective for the short-term relief of symptoms associated with endometriosis as safety concerns like decreased bone mineral density and hot flushes limit its long-term use. Further, both medical and surgical treatments are associated with high relapse rates which commonly result in the use of different combinations of the available treatment options and even repeat surgical procedures. Therefore, there is a need for new treatment options.
Visanne's efficacy and tolerability in treatment of endometrosis have been proven in several clinical studies. To date, more than 700 women have been treated with Visanne for up to 15 months. First data of the study results were presented at the annual meeting of the American Society for Reproductive Medicine (ASRM) in November 2008. Further data are planned for publication.