Kisunla is not a cure and slows worsening memory and cognitive problems by about seven months. The FDA approved a similar drug from a Japanese drugmaker last year.
By Matthew Perrone, Associated PressThis image provided by Eli Lilly shows the company's new Alzheimer’s drug Kisunla. The Food and Drug Administration approved Eli Lilly’s Kisunla on Tuesday, July 2, 2024 for mild or early cases of dementia caused by Alzheimer’s.
Physicians who treat Alzheimer’s say the approval is an important step after decades of failed experimental treatments. 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.Costs will vary by patient, based on how long they take the drug, Lilly said.
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. “Certainly getting an infusion once a month is more appealing than getting it every two weeks,” Schindler said.In the company’s study, patients were taken off Kisunla once their brain plaque reached nearly undetectable levels. Almost half of patients reached that point within a year. Discontinuing the drug could reduce the costs and safety risks of long-term use. It’s not yet clear how soon patients might need to resume infusions.
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FDA approves Eli Lilly’s Alzheimer’s drug KisunlaBerkeley Lovelace Jr. is a health and medical news reporter for NBC News.
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