Summarized by Masters of Longevity from Longevity Technology.
How regulatory leaders are thinking about integrating aging into drug approval pathways and what kinds of studies and measures that discussion would prompt.
Key Takeaways
- FDA officials said early approvable trials will likely target prevention of age-related comorbidities or mortality with enriched populations.
- The agency emphasized developing a shared, qualified endpoint or biomarker suite that links aging processes to clinical outcomes.
- Sponsors must avoid confounding from repurposed drugs by using restrictive eligibility and multi-domain endpoints beyond known drug effects.
