The Food and Drug Administration approved Eli Lilly's Kisunla on Tuesday for mild or early cases of dementia caused by Alzheimer'sdrug that can modestly slow the disease, providing a new option for patients in the early stages of the incurable, memory-destroying ailment.approved Eli Lilly's Kisunla on Tuesday for mild or early cases of dementia caused by Alzheimer's.
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 FDA's prescribing information tells doctors they can consider stopping the drug after confirming via brain scans that patients have minimal plaque.
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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