This summer, the Food and Drug Administration approved a new drug to treat Alzheimer’s — encouraging, in its way. But Leqembi’s benefits are modest at best, and its risks are pretty considerable.
Shortly before approval, Harvard Medical School professor Jerry Avorn wrote that the drug was a perfect example of how the FDA’s all-or-nothing approval process fails both drugmakers and patients.
Avorn recommended that the FDA develop a middle-ground conditional approval “that would allow a new drug with ambiguous credentials to be used only in a limited way until better evidence is collected.”
That could help patients who desperately need the drug now, while also pushing for additional evidence to make sure it’s really right for other people down the road.