Comment from Michela Gallagher

I am submitting this comment in response to FDA’s request for information on drug repurposing for unmet medical needs. The FDA should review AgeneBio’s AGB101, a patented, low-dose, extended release (qd), re-formulation of levetiracetam to treat mild cognitive impairment due to Alzheimer’s. Cognitive impairment is a national crisis as the population continues to age. Levetiracetam is an FDA-approved small molecule, generically available compound for the treatment of seizure disorders (commercially known as Keppra), AGB-101 showed statistically significant neuroprotection in the entorhinal cortex, and showing improvements in CDR-SB data consistent with approved MCI in AD therapeutics (Kisunla and Liqembi) in an18-month, phase 2b trial. The FDA provided favoarble feedback for progression and a clear path forward. Despite these points, this patented approach has faced development and commercial challenges precisely because there are limited commercial incentives for investors and industry in the 505(b)(2) pathway. The attached document summarizes the rationale for further development both from a governmental policy and scientific perspectives. strongly urge the FDA to consider this program for further development and approval. Current treatment options do not adequately address the early stages of disease for many patients. Mild cognitive impairment due to Alzheimer’s disease is an especially important point of intervention because treatment at this stage may preserve function and delay progression before patients require substantially more care and add significant financial burdens to the overall healthcare system.