Advisors to the Food and Drug Administration have recommended unanimously that the agency approve the Alzheimer’s drug donanemab.
At a meeting Monday, the Peripheral and Central Nervous System Drugs Advisory Committee voted 11-0 that donanemab is effective at slowing down Alzheimer’s in the disease’s early stages and that the drug’s benefits outweigh its risks.
If the FDA follows the committee’s recommendation, donanemab would join a similar drug, sold under the brand name Leqembi, which was Donanemab, which targets the amyloid plaques that build up in the brain of Alzheimer’s patients, has taken an unusually long time to work through the approval process.Both donanemab and Leqembi can cause swelling and bleeding in the brain. These effects are usually not symptomatic, but can be serious and have been linked to several deaths.
At Monday’s meeting, the committee heard from doctors and patients who urged them to approve the drug. Members were especially concerned about people who carry two copies of a gene called APOE4. The gene greatly increases the risk that they will get Alzheimer’s, but it also greatly increases the risk of brain bleeding or swelling when they receive donanemab.
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