FDA Approves Lilly Treatment for Early Symptomatic Alzheimer’s Disease

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On July 2, 2024, Eli Lilly and Company announced that FDA had approved Lilly’s Kisunla (donanemab-azbt), a once-monthly monoclonal antibody injection for IV infusion, indicated for treatment of adults with early symptomatic Alzheimer’s disease, including those with mild cognitive impairment or who are in the mild dementia stage of the disease with confirmed amyloid pathology (1).

The therapy is the first which targets amyloid plaques, excessive buildup of which in the brain can result in thinking or memory issues consistent with Alzheimer’s disease, to be approved in the United States, according to a Lilly press release (1).

A Phase III study showed that people who were least advanced in their disease progression had the strongest responses to Kisunla, but overall, the treatment reduced amyloid plaques in participants by 61% from six months after the start of the study, 80% after 12 months, and 84% after 18 months (1). Cognitive and functional decline was reduced by up to 35%, compared to placebo, at 18 months, with participants’ risk of progressing to the next clinical stage of disease reduced by 39%.

"Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer's disease, who urgently need effective treatment options. We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis,” Anne White, executive vice president and president of Lilly Neuroscience, Eli Lilly and Company, said in the press release. “Each year, more and more people are at risk for this disease, and we are determined to make life better for them."

According to the Alzheimer’s Drug Discovery Foundation (ADDF), anti-amyloid drugs have the potential to become the standard of care in fighting Alzheimer’s disease, but there remains a need to develop multiple novel drugs even after FDA gave the green light to Kisunla (2).

“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, ADDF co-founder and chief science officer (2). “This milestone will not only catalyze the next generation of therapies, but also reframe how we deliver treatments. 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.”

In discussing side effects, Lilly said its therapy can cause amyloid-related imaging abnormalities, which do not usually result in symptoms and can be detected via MRI (1). This condition can present as temporary swelling in different areas of the brain that resolves over time, or as small spots of bleeding in or on the brain’s surface; in rare cases, larger areas of bleeding in the brain are possible and can be serious or life-threatening.

References

1. Eli Lilly and Company. Lilly's Kisunla (donanemab-azbt) Approved by the FDA for the Treatment of Early Symptomatic Alzheimer's Disease. Press Release. July 2, 2024.
2. ADDF. ADDF Statement on FDA’s Traditional Approval of Kinsunla (Donanemab). Press Release. Comment received via email correspondence on July 2, 2024.