Alzheimer’s drug Leqembi gets full FDA approval, though efficacy questioned

US officials have granted full approval to a closely watched Alzheimer’s drug, clearing the way for Medicare and other insurance plans to begin covering the treatment for people with the brain-robbing disease.

The Food and Drug Administration endorsed the IV drug, Leqembi, for patients with mild dementia and other symptoms caused by early Alzheimer’s disease. It’s the first medicine that’s been convincingly shown to modestly slow the cognitive decline caused by Alzheimer’s.

Japanese drugmaker Eisai received conditional approval from the FDA in January based on early results suggesting Leqembi worked by clearing a sticky brain plaque linked to the disease.

Eisai studied the drug in people with early or mild disease who were evaluated using a scale measuring memory, thinking and other basic skills. After 18 months, those who got Leqembi declined more slowly — a difference of less than half a point on the scale — than participants who received a dummy infusion. Some Alzheimer’s experts say that delay is likely too subtle for patients or their families to notice.

But federal health advisers said the difference could still be meaningful and recommended that the FDA fully approve the drug at a public meeting in June.