Special Update on Alzheimer’s Drugs Leqembi (lecanemab) and Kisunla (donanemab)
Dear Readers,
The regular Ask a Patient Health News Drug Safety Newsletter is on break this week, and will return on Sunday, July 27.
Today we’re sharing an update on two recently approved Alzheimer drugs, Kisunla (approved in July 2024) and Leqembi (approved in January 2023) both of which have been approved to treat early stages (mild cognitive impairment or mild dementia stage) of Alzheimer disease. Alzheimer’s disease is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks. The drug works by slowing the progression of the disease by reducing the number of amyloid plaques (thought to be a contributing factor to Alzheimer’s) in the brain.
Kisunla’s boxed warning was modified to add that the severe side effect of ARIA (Amyloid Related Imaging Abnormalities) can be fatal. ARIA-E (for edema/effusion) often includes temporary swelling in areas of the brain. It usually occurs early in treatment and is asymptomatic, although serious and life-threatening events like seizures can occur. Kisunla also received approval for a new dosing regimen that clinical trials show have a reduced incidence of the ARIA side effects compared with the previous dosing guidelines.
https://www.fiercepharma.com/pharma/eli-lilly-kisunla-wins-fda-nod-new-dosing-fewer-brain-side-effects-alzheimers-disease
Link to revised Kisunla Drug Label
Leqembi’s cost effectiveness is being challenged by regulators in Japan, who say that at annual cost of 2.98 million yen ($20,300), the price must fall sharply to justify public reimbursement. In the U.S., the cost of the drug is $26,500 and is only partially covered by Medicare.
https://www.thepharmaletter.com/biotechnology/leqembi-costeffectiveness-questioned-in-japan-as-pricing-debate-intensifies
Leqembi Adverse Events Interactive Dashboard
Since Alzheimer’s treatment Leqembi’s (lecanemab) approval in January 2023, sponsor Eisai estimates that around 13,500 U.S. patients have taken it. How has it gone since then, in terms of severe side effects? So far, 1,877 adverse event case reports have been received by the FDA, mainly for patients in the U.S. and Japan. Although (72%) of the reported events were considered “non-serious,” a total of 57 patients died and 311 were hospitalized. Read more about Leqembi and explore the data with our new interactive dashboard. This tool is best used on a desktop computer or larger screen, like a tablet. Please share any suggestions for the tool in the comments below on through our Contact Us page.
https://www.askapatient.com/research/leqembi-interactive-dashboard-adverse-events.asp
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