P115: The Multimorbidity Pivot: Aligning FDA and EMA Frameworks for Geroscience-Based
Therapeutics
Poster Presenter
Jackson David Hanf
Student
University of Southern California United States
Objectives
To evaluate current FDA (Federal Drug Administration) and EMA (European Medicines Agency) regulatory workarounds and propose a harmonized framework for approving longevity therapeutics by shifting from single-disease indications to the prevention of age-related multimorbidity.
Method
A comparison of US (Regenerative Medicine Advanced Therapy) and EU (Priority Medicines) pathways, along with case studies, was conducted to identify gaps in biomarker validation, endpoint acceptance, and the regulatory feasibility of aging as an indication.
Results
Current drug development in the longevity space is hindered by a regulatory mismatch in which biological aging mechanisms (hallmarks and biomarkers) do not align with ICD-coded disease
Categories, the global standard for diagnostic classification. The International Classification of Diseases (ICD) is the global standard for diagnostic health information. Research findings show that leading biotech firms currently utilize an “Indication-First Strategy,” targeting recognized
conditions such as osteoarthritis (senolytics) or sarcopenia (mammalian target of rapamycin modulation) to secure initial market access.
However, our analysis highlights the TAME (Targeting Aging with Metformin) trial as a
critical turning point, successfully securing FDA acceptance for a “Composite Endpoint” to
assess aging. A composite endpoint is a clinical trial outcome that combines several different events into a single measure to determine if a drug is effective. This model defines success not by the cure of one disease, but by the delayed onset of any major age-related event (cardiovascular disease, cancer, or cognitive decline). This introduces a potential regulatory model centered on the “Prevention of Age-Related Multimorbidity”. Furthermore, the emergence of the Plausible Mechanism Pathway and Advanced Research Projects Agency for Health’s 2026 investments in healthspan biomarkers reflect increasing regulatory interest in “Target Engagement” based approval models. Despite this progress, including the lack of a validated “gold standard” biological clock, limited cross-agency harmonization on surrogate endpoints, and an extremely low toxicity tolerance for preventative drugs in healthy populations.
Conclusion
The future of geroscience depends on a fundamental regulatory shift from reactive sick-care to proactive healthcare. To bridge the current regulatory gap, we propose that agencies must work towards a harmonized framework that formally recognizes validated surrogate biomarkers and morbidity endpoints as acceptable clinical endpoints for aging-related indicators. Aligning Western definitional and regulatory frameworks approaches FDA and EMA will reduce market entry barriers and de-risk investment in the geroscience sector. By adopting the multimorbidity pivot, regulators can provide a standardized roadmap for longevity therapeutics that allows
hallmark-targeting therapies to legally and safely extend human healthspan.
