Bionovo today announced that the FDA has approved the company’s total clinical
development plan for Menerba, the company’s drug candidate for menopausal hot
flashes.
“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,” said Mary Tagliaferri, M.D., Bionovo’s President and Chief
Medical Officer. “While we are awaiting the formal minutes from the FDA
meeting, we are moving forward to implement the agency’s suggestions and have
forwarded the approved clinical trial design to our investigators and their
investigational review boards, or IRBs.”
“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,” said
Isaac Cohen, Bionovo’s Chairman and Chief Executive Officer. “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.”
