Bionovo, Inc. is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women’s health and cancer, including Menerba, the company’s oral drug candidate for menopausal hot flashes.
The company today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s total clinical development plan for Menerba. While the company waits on formal minutes from its meeting with the FDA, Bionovo said it has passed along relevant information to the company’s investigators and investigational review boards.
“We had a very positive meeting with the FDA on our clinical program for Menerba. As anticipated, they agreed with our overall clinical development plan which included the number of clinical trials, number of subjects and length of exposure as well as non-clinical studies necessary for New Drug Application (NDA) submission for a non-estrogen drug such as Menerba. They also provided useful suggestions for improving the clinical trial protocols,” Mary Tagliaferri, M.D., Bionovo’s president and chief medical officer stated in the press release.
Menerba was developed as an alternative to similar products currently on the market, which have been linked to increased risk of breast and uterine cancers. Menerba differs from currently marketed products in that its active ingredients are derived from botanicals deemed safe and effective for use in traditional Chinese medicine. As such, the company recognizes the need for and market potential of such a product.
“Menerba is a first-in-class, unique drug candidate that is intended for a large medical need, for the safe and effective treatment of menopausal symptoms,” Isaac Cohen, Bionovo’s chairman and CEO stated. “We want to do everything necessary to bring Menerba to market for the treatment of hot flashes, while we also investigate its potential use in the treatment of breast cancer prevention. Now that we have agreements with the FDA and the EMA (the European Medicines Agency) on the overall development of Menerba, we have accelerated discussions with potential partners to successfully bringing Menerba to market.”
For more information, visit www.bionovo.com