……………..catching up on recent FDA approvals
The FDA recently approved a new therapy, Kisunla (donanemab-azbt) from Eli Lilly and Company, indicated for the treatment of adults with early symptomatic Alzheimer’s Disease (AD). Approval includes people with mild cognitive impairment (MCI) as well as people with the mild dementia stage of AD, with confirmed amyloid pathology.
Kisunla is administered monthly by infusion and the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed. As noted in our Reports on FDA approvals of other recently approved therapies for AD, amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. It is believed that excessive buildup of amyloid plaques in the brain can lead to memory and thinking issues associated with AD. Kisunla can help the body remove the excessive buildup of amyloid plaques.
The price of each vial of Kisunla is $695.65. The total cost of Kisunla will vary by patient based on the removal of amyloid plaques to minimal levels as observed on amyloid PET imaging. As such, sample costs associated with the therapy can range from ~ $12,500 (6 months), to $32,000 (12 months), to $48,700 (18 months), etc.
The company indicated that Kisunla will launch through specialty pharmacy limited distribution.
Click here to access prescribing information
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