This image provided by Eli Lilly shows the company's new Alzheimers drug Kisunla. The Food and Drug Administration approved Eli Lillys Kisunla on Tuesday, July 2, 2024 for mild or early cases of dementia caused by Alzheimers. 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 theThe 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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