United States – Eli Lilly said on Tuesday that the Food and Drug Administration (FDA) had endorsed its Alzheimer’s drug, which means that it will become another addition to the market of new-generation products that can only temporarily detain the disease progress.
Advisory Committee Review
Earlier in the year the FDA in early march paused its approval of donanemab and then convened an advisory committee to review the safety of the drug. This particular panel meeting was a shocker to the company since they had complied in their application 2023 waiting for the approval before mid 2024. The consultants of the FDA recommended a approval of the drug, as reported by The Hills.
Mechanism and Availability
Marketed as Kisunla, donanemab is a monoclonal antibody that binds to amyloid plaques in the brain. It is designed for early-stage Alzheimer’s and is administered once a month through drip infusion. Eli Lilly stated that the drug will be available in the coming weeks.
Clinical Trial Results
In an 18-month trial involving 1,700 patients with early-stage Alzheimer’s, donanemab reduced disease progression by 35% compared to a placebo, delaying progression by approximately three to four months. However, some severe adverse effects were reported, including three deaths from brain bleeding or swelling.
Impact and Comparison
At the moment, there are more than 6 million Alzheimer patients in the United States, and this figure is set to grow due to the increasing proportion of elderly people. Donanemab is the third amyloid-targeting Alzheimer’s drug approved by the FDA since 2021, in addition to Aduhelm and Leqembi. While Leqembi treatment cannot be discontinued upon significant plaque burden decrease, donanemab treatment can be stopped once the reduction of the deposits is reached, which may result in less costs and fewer infusions, as reported by The Hills.
Cost and Insurance Coverage
Every vial of Kisunla costs USD 695.65 that is approximately USD 32,000 for each year. The final cost will, therefore, depend on the time that the treatment will take. Medicare Part B will pay for the drug with patients to pay coinsurance of 20% after the deductible.