Alzheimer's disease: the United States approves a new drug

By Alice Bruschi Last updated Jul 16, 2024

Green light to market a new Alzheimer’s treatment that can slow disease progression by up to 35%

Alzheimer’s disease: some facts about the disease

Alzheimer’s is the most common form of dementia that predominantly affects the elderly after age 65 and is characterized by a progressive decline in cognitive functions, starting with memory. This neurodegenerative disease has a devastating impact on the lives of patients and their families. There are currently more than 55 million people affected globally, with an estimated growing number that could reach 78 million by 2030, making it the seventh leading cause of death.

New drug, new hope

Recently, a glimmer of hope has arisen in the Alzheimer’s treatment landscape. The U.S. Food and Drug Administration (FDA) recently gave the green light to market a new treatment against this disease. Developed by the U.S. Eli Lilly Laboratory, the new treatment is based on the intravenous injection of Donanemab (or Kisunla), a monoclonal antibody, which has been shown to slow disease progression by up to 35 percent, with effects most pronounced in patients treated in the early stages.

A novel mechanism of action

As explained by the FDA, the drug works by attacking amyloid plaques present in the brains of Alzheimer’s patients, and responsible for neuronal dysfunction. It is a treatment based on immunotherapy, a process that activates immune cells to eliminate these plaques. At the end of several trials, clinical trials showed that Donanemab slowed cognitive decline by 35 percent in early-stage patients and by 22.3 percent in the overall sample. It also reduced amyloid plaques by up to 84 percent after 18 months of treatment.

A long approval process: the side effects of Donanemab

The approval process for this drug was long and complex because of the serious side effects associated with administering the new drug. Indeed, Donanemab, while offering hope, can cause serious side effects, including ARIA (Amyloid-Related Imaging Abnormalities), a condition involving brain swelling or microhemorrhages, and brain hemorrhage. Last year the FDA had rejected approval of the drug, but in early June an agency advisory committee recommended full approval of the treatment, saying that “the benefits of the therapy outweigh the risks.”

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