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

This 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.

The delay seen with both drugs amounts to a matter of months — about seven months, in the case of Lilly’s drug. Patients and their families will have to weigh that benefit against the downsides, including regular IV infusions and potentially dangerous side effects like brain swelling. Both Kisunla and the Japanese drug, Leqembi, are laboratory-made antibodies, administered by IV, that target one contributor to Alzheimer's — sticky amyloid plaque buildup in the brain. Questions remain about which patients should get the drugs and how long they might benefit.

The main safety issue was brain swelling and bleeding, a problem common to all plaque-targeting drugs. The rates reported in Lilly's study — including 20% of patients with microbleeds — were slightly higher than those reported with competitor Leqembi. However, the two drugs were tested in slightly different types of patients, which experts say makes it difficult to compare the drugs' safety.

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