Eli Lilly recently announced that the U.S. Food and Drug Administration (FDA) has established a committee to evaluate donanemab, the Alzheimer’s drug that had its approval blocked last year. The committee is expected to convene later this year before the FDA makes a final decision about approving donanemab.

Donanemab is one of three monoclonal antibody treatments for Alzheimer’s that includes aducanumab (Aduhelm) and lecanemab (Leqembi). All three drugs work by clearing the amyloid plaques that are characteristic of Alzheimer’s, but there was scarce evidence in early trials that clearing the plaques slowed cognitive decline.

In a trial last year, donanemab showed “significantly slowed clinical progression” in early Alzheimer’s patients but also produced brain swelling and other adverse effects.

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