FDA OKs Another Drug for Early Alzheimer’s Disease

Neurology
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Alzheimer’s Disease

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Decision gives patients a second anti-amyloid treatment option

by
Judy George,

Deputy Managing Editor, MedPage Today

July 2, 2024

The FDA approved donanemab (Kisunla) for the treatment of adults with early symptomatic Alzheimer’s disease with confirmed amyloid pathology, the agency announced Tuesday. This includes Alzheimer’s patients with mild cognitive impairment and mild dementia.

The once-monthly treatment is the only anti-amyloid agent with evidence to support stopping therapy when amyloid plaques are removed, drugmaker Eli Lilly said.

The FDA’s decision gives early Alzheimer’s patients a second anti-amyloid treatment option after the agency’s full approval of lecanemab (Leqembi) in 2023.

“This approval is emblematic of the new era of Alzheimer’s research where we now have the first class of disease-modifying drugs that will eventually be used in combination with novel therapies — based on the biology of aging — that target all the underlying complexities of this disease,” said Howard Fillit, MD, of the Alzheimer’s Drug Discovery Foundation in New York City, in a statement.

“This milestone will not only catalyze the next generation of therapies, but also reframe how we deliver treatments,” Fillit continued. “It’s promising to see that some patients essentially enter remission, where they achieve full amyloid clearance with no resurgence in substantial plaque buildup for several years to follow.”

The FDA decision comes less than a month after its advisory committee unanimously supported donanemab for early Alzheimer’s disease, after weighing its risks and benefits.

Donanemab was tested in the phase III TRAILBLAZER-ALZ 2 trial of 1,736 early Alzheimer’s patients. The drug met the trial’s primary endpoint of change from baseline in the Integrated Alzheimer’s Disease Rating Scale, slowing decline relative to placebo (P