FDA Only Approves Drugs That Fight Diseases and FDA Does Not See Aging as a Disease

(p. R2) Will people eventually routinely live—and live healthily—longer? That’s the vision of the burgeoning field of aging research, where scientists are trying to extrapolate tantalizing life-prolonging findings from animal experiments into medicines that slow, prevent or even reverse the aging process for humans.

Leading candidates for stanching aging include two familiar drugs—metformin, a front-line diabetes treatment, and rapamycin, long used to prevent transplant patients from rejecting donated organs. Both have been shown to increase longevity in animal studies and both target molecular processes linked to the aging of cells.

Another approach is a new class of drugs called senolytics, which clear the body of so-called senescent cells, old cells that stop dividing but don’t die. They accumulate in tissues throughout the body and secrete factors that damage other cells. They are linked to such aging conditions as frailty, cognitive impairment and lack of physical resilience.

Also in the mix is a strategy called cellular reprogramming in which scientists are seeking to turn back the clock on aging cells, restoring functions characteristic of younger cells.

. . .

. . ., the Food and Drug Administration doesn’t recognize aging as a disease to be treated, meaning there isn’t a clear path to approval for a drug that targets the biology of aging. Researchers instead have to design trials that can quantify whether a drug improves health or extends survival in a specific age-related disease. A pill that a large and generally healthy population would take, perhaps for decades, would have to clear a high safety bar.

. . .

Researchers are working to develop biomarkers in blood or other bodily sources that can quantify the aging process and serve as drug targets or as proxies to indicate a drug is working or not. Without validated biomarkers, it could take 20 or 30 years in some cases to run a randomized trial to prove whether a drug safely extended life.

For the full story, see:

Ron Winslow. “A Pill to Turn Back the Clock.” The Wall Street Journal (Thursday, Jan. 13, 2022): R2.

(Note: ellipses added.)

(Note: the online version of the story has the date January 11, 2022, and has the title “Can You Fight Aging? Scientists Are Testing Drugs to Help.”)

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