In its press release the company says it continues to believe in the value that flibanserin would have for women suffering with HSDD, a significant and recognised medical condition which impacts the lives of many women around the world.
"The decision was not made lightly, considering the advanced stage of development," said Professor Andreas Barner, chairman of the board of managing directors and responsible for the Corporate Board Division Pharma Research, Development and Medicine. "We remain convinced of the positive benefit-risk ratio of flibanserin for women suffering with HSDD."
The response of the authorities and the complexity and extent of further questions that would need to be addressed to potentially obtain registration for flibanserin have impacted the company's decision to focus on other pipeline projects. The company regularly reviews its pipeline projects and updates its priorities accordingly.
In June 2010, the Reproductive Health Drugs Advisory Committee met in Washington to discuss the new drug application (NDA) for flibanserin as a treatment for HSDD in pre-menopausal women. Members of the committee advised that additional data would be necessary to further support the efficacy and safety profile of flibanserin.
Following the Advisory Committee meeting in June, the US Food and Drug Administration (FDA) issued its Complete Response Letter to the NDA at the end of August.
Boehringer Ingelheim says it is proud to have contributed to an increased understanding of HSDD through its significant investment into research, development and educational activities. The company will complete the two most advanced clinical studies to add knowledge for the scientific community and women suffering with HSDD.
"The need for a better understanding of HSDD and its possible treatment continues, and we hope the scientific and medical communities will build on the knowledge that the company's research has provided to find solutions for women who suffer with this disorder," said Michael Sand, director, Clinical Research and Global Strategic Leader of flibanserin, Boehringer Ingelheim.
In view of the broad range of therapeutic areas that the company's pipeline currently comprises, the company will be able to re-allocate resources to other areas, such as stroke prevention, diabetes and oncology.
