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

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. 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.

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.

First, doctors need to confirm that patients with dementia have the brain plaque targeted by the new drugs. Then they need to find a drug infusion center where patients can receive therapy. Meanwhile, nurses and other staff must be trained to perform repeated scans to check for brain swelling or bleeding.

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