Will the FDA approve any drug for an aging indication in humans before January 1, 2035?
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Desactualizado1 oct 26, 16:19 UTC31 dic 34, 23:59 UTC
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Resolves YES if, before January 1, 2035, the FDA approves (via CDER or CBER, any pathway including accelerated approval) a drug or biologic whose approved labeling names aging, biological aging, lifespan extension, healthspan extension, or the delay of multiple age-related diseases as such (rather than a specific disease) as an indication.
- Approval for a single age-related disease (for example Alzheimer's disease, osteoarthritis, sarcopenia) does not count.
- Otherwise NO.
- Background: No drug has been approved for aging as an indication in humans; aging is not a recognized indication at the FDA, which is why the proposed TAME trial of metformin targets a composite of age-related diseases (Barzilai et al., Cell Metabolism 2016).
- In dogs, by contrast, the FDA Center for Veterinary Medicine has accepted reasonable-expectation-of-effectiveness and target-animal-safety sections for lifespan-extension drugs under its expanded conditional approval pathway.
- See the companion question: Will the FDA conditionally approve a drug to extend lifespan or healthspan in dogs before January 1, 2028? Sources: https://doi.org/10.1016/j.cmet.2016.05.011 CVM Guidance for Industry #261 @/w0lph/will-the-fda-conditionally-approve https://w0lph.github.io/k9/why-dogs.html
