The U.S. Food and Drug Administration has approved a new medication for people with Alzheimer’s disease. Eli Lilly’s Kisunla is a once-monthly injection intended for adults with early symptomatic Alzheimer's disease, according to a press release from the company. Eligible patients include those with mild cognitive impairment and those who have mild dementia with confirmed amyloid pathology.
This is the first medication to target amyloid plaques — the proteins that build up in the brains of Alzheimer’s patients, often impairing memory and cognitive function — with evidence to support stopping therapy when amyloid plaques are removed, the release stated.
Fox News Digital reached out to the company for further comment. The drug is designed to remove excessive buildup of amyloid plaques and slow cognitive decline, according to the company. The approval follows an advisory panel’s recommendation of the drug at the FDA's Peripheral and Central Nervous System Advisory Committee hearing last month.
In phase 3 trials published in May 2023, donanemab was shown to 'significantly slow cognitive and functional decline in people with early symptomatic Alzheimer's disease,' according to a press release on Eli Lilly’s website. That study was published by the Journal of the American Medical Association. The most serious potential side effect of Kisunla is amyloid-related imaging abnormalities , which can lead to temporary brain swelling or bleeding.
Although this effect 'usually resolves over time,' it can be life-threatening, the company said. Some patients may also experience headaches or potentially serious allergic reactions during or shortly after the drug’s infusion. Dr.