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Ingelheim/Germany, 18 June 2010 – The Reproductive Health Drugs Advisory Committee met today to discuss the new drug application (NDA) for flibanserin 100 mg as a treatment for Hypoactive Sexual Desire Disorder (HSDD) in pre-menopausal women. The advisory committee was convened by and makes recommendations to the U.S. Food and Drug Administration (FDA). The FDA will consider the committee’s advice as part of its final assessment of the NDA.
The committee recognised the significant unmet medical need for women with HSDD and the lack of approved treatments for this condition. Members of the committee advised that additional data are necessary to further support the efficacy and safety profile of flibanserin and recommended that clinical development of the drug continue.
"We are disappointed with the advisory committee’s recommendations and will work with the FDA to address questions raised by the advisory committee," said Christopher Corsico, M.D., M.P.H., U.S. medical director, Boehringer Ingelheim Pharmaceuticals, Inc. "Our ongoing flibanserin clinical trial programme demonstrates our continued commitment to women with HSDD."
This release is from the Corporate Headquarters of Boehringer Ingelheim and is intended for international markets. This being the case, please be aware that there may be some differences between countries regarding specific medical information including licensed uses. Please take account of this when referring to the material.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 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 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro while spending 21% of net sales in its largest business segment Prescription Medicines on research and development.