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news.The US Food and Drug Administration (FDA) has accepted the Bionovo's Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate, Menerba, in a type 'B' or 'End of Phase 2' meeting.
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Menerba is an oral, botanically-derived estrogen receptor beta (ER-b) selective drug candidate designed for the safe, effective treatment of vasomotor symptoms (hot flashes) associated with menopause.
With this designation, the decisions and agreements are now considered binding on Bionovo and the FDA.
Bionovo is now in final discussions with the FDA to complete the design of the Phase 3 pivotal trials in the US following the FDA’s approval of its CMC plan.
The company also received approval of the clinical and CMC development plan from the European Medicines Agency (EMA) for Menerba.
The EMA ‘final guidance’ defines the clinical and regulatory pathway to a European marketing authorisation for Menerba, and is also considered binding and definitive.