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Promising Alzheimer’s drug Donanemab set for FDA approval by end of year

The landscape of Alzheimer’s disease treatment is changing rapidly, with another drug making substantial progress in clinical trials only a week after lecanemab received full FDA approval. Donanemab, developed by Eli Lilly and Company, targets the Beta Amyloid in the brain responsible for Alzheimer’s disease. This investigational antibody is anticipated to gain FDA approval by the end of this year. Initial studies indicate that Donanemab may produce even better outcomes than its predecessors.


Donanemab has been designated as a breakthrough therapy by the FDA, a status that facilitates accelerated development and review, aiming to help those currently diagnosed with Alzheimer’s disease. Clinical trials have found that Donanemab can slow the progression of Alzheimer’s disease in its earliest, symptomatic stages by up to 60%. If approved, the drug could potentially extend treatment options to the nearly 6 million Americans living with Alzheimer’s. However, its use is limited to those in the earliest stages of the disease.

Lauren Ashburn, the Associate Director of Advocacy for the Alzheimer’s Association of the Western New York Chapter, emphasizes the promising results of this medication. Donanemab’s impact extends beyond the treatment period, with the disease ceasing to progress even after patients stopped taking the drug. However, as with other medications, donanemab may have side effects, including potentially severe brain swelling and bleeding. Medical experts thus advise patients to seek a diagnosis and discuss the potential risks and benefits with their doctors.