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FDA approves Leqembi, second Alzheimer's drug to target disease's pathophysiology
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Leqembi is the second of a new category of medications approved for Alzheimer's disease that target the fundamental pathophysiology of the disease.

Alzheimer's disease is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills. Leqembi works by targeting amyloid beta plaques, which are a hallmark of Alzheimer's disease. Amyloid beta plaques are thought to contribute to the development of Alzheimer's disease by damaging neurons and their connections.

The FDA approved Leqembi using the Accelerated Approval pathway, which allows for the approval of drugs for serious conditions where there is an unmet medical need and a drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. In the case of Leqembi, the surrogate endpoint was a reduction in amyloid beta plaques.

A clinical trial found that patients who received Leqembi had a significant reduction in amyloid beta plaques compared to patients who received a placebo. The trial also found that patients who received Leqembi had a slower decline in cognitive function than patients who received a placebo.

The most common side effects of Leqembi were infusion-related reactions, headache, and amyloid-related imaging abnormalities (ARIA). ARIA is a temporary swelling in areas of the brain that usually resolves over time. Some people may also experience small spots of bleeding in or on the surface of the brain.

Leqembi is indicated for the treatment of Alzheimer's disease in patients with mild cognitive impairment or mild dementia. It should not be used in patients with severe Alzheimer's disease.

The approval of Leqembi is a significant advancement in the treatment of Alzheimer's disease. Leqembi is the second drug to target the underlying pathophysiology of Alzheimer's disease, and it offers the potential to slow the progression of the disease and improve cognitive function. (ILKHA)



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