INDIANAPOLIS, Ind. – The Food and Drug Administration granted approval on Tuesday to a highly anticipated Alzheimer’s drug called Kisunla, manufactured by Eli Lilly. This approval comes after a delay in March to further assess the drug’s safety and effectiveness. The drug was greenlit by the FDA following a panel of independent experts unanimously endorsing it in May.
Kisunla, the brand name for donanemab, is one of the few Alzheimer’s treatments that actually modifies the underlying disease. It will now join only one other drug, Leqembi, on the commercial market. While Kisunla does not halt the progression of the disease, it has shown to slow cognitive and functional decline in patients with early symptomatic Alzheimer’s disease.
Eli Lilly’s chief scientific officer, Daniel Skovronsky, expressed his optimism about Kisunla, noting the limited treatment options available for such a feared disease like Alzheimer’s. The drug will soon be available to patients in the coming weeks to help combat the devastating effects of the disease on families.
The approval of Kisunla is significant as it adds to the arsenal of amyloid-targeting drugs aiming to modify the course of Alzheimer’s disease. While the benefits of Kisunla are statistically significant, some critics argue that they may be modest and could vary depending on the patient’s genetics and disease stage.
The cost of Kisunla will vary depending on the patient’s completion of the treatment, with estimates for a six-month course at $12,522. Medicare is expected to cover the treatment for certain patients, potentially reducing the financial burden on those seeking the medication.
This approval marks a milestone for Eli Lilly and could pave the way for other amyloid-targeting drugs in the fight against Alzheimer’s. While the drug may not be a cure, it offers hope to patients and families impacted by the disease, providing a potential opportunity to slow its progression and improve quality of life.