FDA Approves Eli Lilly’s Drug to Slow Alzheimer’s Disease

Alzheimer’s disease affects more than 6 million Americans, and yet treatment options for the progressive, neurodegenerative disease remain limited.

For those with mild or early-stage Alzheimer’s, however, a new treatment has just been given FDA approval: Eli Lilly’s Kisunla.

The drug, chemically called donanemab, has been shown to moderately slow the progression of disease by helping to remove buildup of amyloid plaque in the brain — a hallmark of Alzheimer’s. While amyloid is a protein produced naturally in the body, it can clump together to create amyloid plaques, and this excessive buildup in the brain may lead to memory and thinking issues associated with Alzheimer's disease.

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Kisunla is the second drug to be approved to slow Alzheimer’s progression, following the approval of Japanese drugmaker Eisai’s Leqembi last year.

The new drug consists of lab-made monoclonal antibodies that are given through a monthly intravenous (IV) infusion.

In clinical trials, the drug was shown to slow cognitive decline by 35% in those with very early disease compared to those who received a placebo, and by 22% in the overall population — which included some individuals with more advanced disease.

Among the two groups, participants treated with Kisunla had up to a 39% lower risk of progressing to the next clinical stage of disease than those taking placebo.

It did also present some serious side effects, including brain bleeding and swelling.

And it doesn’t come cheap. Eli Lilly says a year of Kisunla treatment would cost $32,000, though this depends on an individual’s insurance coverage and length of treatment.

Fortunately, the treatment isn’t meant to go on indefinitely: the company says patients whose amyloid plaque buildup reduces to undetectable levels can stop the drug, at least for some period of time.

While the treatment isn’t cheap or risk-free, experts say its approval is an important step for Alzheimer’s patients who lack treatment options. The disease is incurable, and many attempts to produce experimental treatments have failed in recent years.

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"This approval marks another step forward in evolving the standard of care for people living with Alzheimer's disease that will ultimately include an arsenal of novel treatments, providing much needed hope to the Alzheimer's community," said Howard Fillit, M.D., the co-founder and chief science officer at the Alzheimer's Drug Discovery Foundation (ADDF), in a statement. "Diagnosing and treating Alzheimer's sooner than we do today has the potential to meaningfully slow disease progression, giving patients invaluable time to maintain their independence for longer."

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