As a pro-drug of an approved drug, Memogain should fulfill the requirements for a shortened regulatory approval process in the EU and USA.
EU EMA: The Scientific Advice received from the CHMP suggests that a single, appropriately powered cognition trial of six months duration, in mild to moderately demented AD patients may be sufficient for market authorization of the drug. Based on this advice, Neurodyn’s team of European-based Alzheimer’s experts are planning to complete the Phase I program which includes a Multiple Ascending Dose trial and may include a proof of principal trial designed to demonstrate Memogain’s potential for disease modification. The results of the Phase I program will assist in defining the path to market in the EU, possibly under an Innovative Medicines designation.
US FDA: Neurodyn Cognition has held detailed discussions with a recognized FDA 505(b)(2) regulatory expert. In the opinion of this expert, Memogain qualifies for 505(b)(2), Breakthrough Therapy and Accelerated Approval status. Neurodyn is preparing to meet with the FDA for pre-IND guidance to confirm these designations.