Actinogen Reaches Agreement with the FDA for Future Marketing Approval of Alzheimer’s Disease Treatment

Actinogen Medical Limited announced the successful conduct of its scheduled Type C meeting (written response) on Alzheimer’s disease (AD) with the FDA.

Actinogen and the FDA reached a common understanding of the pathway to marketing approval in AD - meaning agreement on regulatory starting materials in drug substance synthesis, the design of one additional pivotal clinical trial and the limited number of ancillary clinical pharmacology trials and nonclinical studies required. Key understandings include the:

1. ‘Regulatory starting materials‘ for the commercial manufacturing of Xanamem^® (emestedastat) drug substance
2. General design of the interim analysis for XanaMIA
3. Design of one additional, well-controlled, pivotal (phase 3) trial to support a positive XanaMIA pivotal trial
4. Single emestedastat dose design (10 mg vs placebo) for the planned pivotal Phase 3 trial
5. Number of people to be treated with Xanamem to be described in the New Drug Application (NDA) – that is, the makeup of the planned safety database consistent with FDA guidelines
6. Small number of ancillary clinical pharmacology trials to be conducted
7. Nonclinical studies required to further characterize the metabolism and excretion pathways of Xanamem.

The outcome reached at this meeting with the FDA’s Neurology-I Division represents a major milestone for Actinogen as the Company prepares for the earliest possible NDA submission in the US and submissions to other global regulators. It provides important clarity for ongoing discussions with potential development and marketing partners.

A similar meeting for Alzheimer’s disease (AD) will be held with European Medicines Agency in 2026 and subsequently with the UK MHRA¹ and other regulators. Actinogen’s FDA agreement is consistent with the desire of regulators worldwide to find safer and more effective therapies for AD, given the limited effectiveness of currently available treatments.

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