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The U.S. Food and Drug Administration approved a new Alzheimer’s drug named donanemab, marketed as Kisunla, on Tuesday.
This decision came after clinical studies indicated that the drug could decelerate disease symptoms. Developed by pharmaceutical leader Eli Lilly, which also produced the anti-obesity medication Mounjaro, the firm witnessed a slight uptick in shares following the approval.
Eli Lilly has yet to announce a release date for Kisunla. Intended for patients in the initial stages of Alzheimer’s, the treatment consists of a monoclonal antibody administered through an infusion every four weeks. Treatment pricing is set to begin at $12,522 for a half-year, with a full eighteen-month course costing up to $48,696.
The company also confirmed that Medicare patients would have access to Kisunla treatments and be eligible for reimbursement, following a recent agreement that expanded coverage for certain Alzheimer’s therapies as of October 2023.
Kisunla targets the amyloid plaques in the brain, which are linked to the cognitive impairments symptomatic of Alzheimer’s disease. While the role of these plaques in Alzheimer’s progression remains a topic of scientific debate, trials for Kisunla demonstrated a reduction in plaque levels and a deceleration in the advancement of symptoms.
The pivotal phase 3 trial included 1,736 participants between the ages of 60 and 85, all diagnosed with Alzheimer’s. Patients either received Kisunla or a placebo. Results revealed a 35% slower progression in those treated with Kisunla, based on a comprehensive six-part test assessing various cognitive and functional abilities.
However, the treatment was not without risks. Three trial participants died from severe side effects linked to a condition known as amyloid-related imaging abnormalities (ARIA), which can cause brain swelling and bleeding.
An early trial participant, 79-year-old Pat Bishara from Carmel, Indiana, who was diagnosed in 2017, shared her positive experience with the drug, noting improvements in her condition despite occasionally struggling with recalling names.
With this FDA approval, Kisunla is set to rival Leqembi, a similar Alzheimer-protein targeting drug approved last July, produced by Biogen and Eisai. Both medications have shown comparable efficacy in clinical trials.
For more detailed coverage, visit The Daily Beast’s website.