Bionovo, Inc. (Nasdaq: BNVI, BNVID) announced today that the U.S. Food and Drug Administration (FDA) accepted the Company's Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate, Menerba®, in a Type "B" or "End of Phase 2" meeting. With this designation, the decisions and agreements are now considered binding on the Company and the FDA.
"This CMC approval represents a revolutionary set of 'firsts'," said Dr. Isaac Cohen, Bionovo's Chairman and Chief Executive Officer. "This is the first time that the FDA's botanical drug development CMC guidance has been applied to an oral drug in a major indication. This is also the first time in recent history that the FDA has reviewed and approved a manufacturing plan for a drug with multiple actives derived from botanical source. In addition, Menerba, may be the first in class selective estrogen receptor beta modulator to go into late stage development. After long effort, innovations and interaction, Bionovo has now opened the door for a new paradigm in drug development."
With the FDA's approval of the Company's CMC plan, Bionovo is now in final discussions with the FDA to complete the design of the Phase 3 pivotal trials in the U.S. Having just successfully concluded a non-binding teleconference with the FDA, the Company has requested a face-to-face meeting, for the approval of the clinical development plan. The FDA is expected to grant such a meeting shortly.
As previously disclosed, 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 authorization for Menerba, and is also considered binding and definitive.
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