Second Alzheimer's drug approved by the FDA

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Second Alzheimer's drug approved by the FDA
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West Texas Chapter of the Alzheimer's Association said those with Alzheimer's or dementia can still be included in the celebrations.

The drugs can delay symptoms of the disease by a matter of months, but come with potentially dangerous side effects.The Food and Drug Administration approved Eli Lilly’s Kisunla on Tuesday for mild or early cases of dementia caused by Alzheimer’s. It’s only the The delay seen with both drugs amounts to a matter of months — about seven months, in the case of Lilly’s drug.

The new drug's approval was expected after an outside panel of FDA advisors unanimously voted in favor of its benefits at a public meeting last month. That endorsement came despite several questions from FDA reviewers about how Lilly studied the drug, including allowing patients to discontinue treatment after their plaque reached very low levels.

The FDA approved Kisunla, known chemically as donanemab, based on results from an 18-month study in which patients given getting the treatment declined about 22% more slowly in terms of memory and cognitive ability than those who received a dummy infusion.. The rates reported in Lilly's study — including 20% of patients with microbleeds — were slightly higher than those reported with competitor Leqembi.

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