FDA approves a second Alzheimer's drug that can modestly slow disease

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.

“I’m thrilled to have different options to help my patients,” said Dr. Suzanne Schindler, a neurologist at Washington University in St. Louis. “It’s been difficult as a dementia specialist — I diagnose my patients with Alzheimer’s and then every year I see them get worse and they progress until they die.”are laboratory-made antibodies, administered by IV, that target one contributor to Alzheimer's — sticky amyloid plaque buildup in the brain.

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.

“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 low levels. More than 40% of patients stopped taking the drug after one year. Discontinuing the drug could reduce the costs and safety risks of long-term use. It's not yet clear when patients might need to resume infusions.of competitor Leqembi, which Eisai co-markets with U.S. partner Biogen.

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