Preprint on Alzheimer’s drug deaths ignites dispute among authors
“Infighting among a group of prominent Alzheimer’s disease researchers has led to the withdrawal of a preprint they co-authored, which suggested a new Alzheimer’s drug markedly increases the risk of death. One scientist involved in the work charges the senior author failed to seek the go-ahead from his co-authors before posting an edited version of the article to a preprint server.”
FDA OKs Another Drug for Early Alzheimer’s Disease
The FDA approved donanemab (Kisunla) for the treatment of adults with early symptomatic Alzheimer’s disease with confirmed amyloid pathology, the agency announcedopens in a new tab or window Tuesday. This includes Alzheimer’s patients with mild cognitive impairment and mild dementia.
The once-monthly treatment is the only anti-amyloid agent with evidence to support stopping therapy when amyloid plaques
The Food and Drug Administration on Tuesday approved a new drug for Alzheimer’s disease, the latest in a novel class of treatments that has been greeted with hope, disappointment and skepticism.
The drug, donanemab, to be sold under the brand name Kisunla, was shown in studies to modestly slow the pace of cognitive decline in early stages of the disease. It also had significant safety risks, including swelling and bleeding in the brain.
Kisunla, made by Eli Lilly, is similar to another drug, Leqembi, approved last year. Both are intravenous infusions that attack a protein involved in Alzheimer’s, and both can slow the unfolding of dementia by several months. Both also carry similar safety risks. Leqembi, made by Eisai and Biogen, is given every two weeks; Kisunla is given monthly.
Kisunla has a significant difference that may appeal to patients, doctors and insurers: Lilly says patients can stop the drug after it clears the protein, amyloid, which clumps into plaques in the brains of people with Alzheimer’s.
“Once you’ve removed the target that you’re going after, you then can stop dosing,” said Anne White, an executive vice president of Lilly and president of its neuroscience division. She said that this could reduce the overall cost and inconvenience of the treatment as well as the risk of side effects.
“As Science noted in its story on the retracted paper, scientists are still debating whether the amyloid theory is viable. The skeptics cite the fraudulent research and lack of a genuine breakthrough; supporters can point to this new class of drugs including donanemab that have led to some improvement in some patients.”
“Last week, a panel of independent advisers to the FDA unanimously voted in support of Eli Lilly’s donanemab, a competitor in the same class of drugs that target amyloid plaques in the brain. The FDA is expected to decide on whether to approve the drug by the end of the year.
Life expectancies around the world have surged in recent decades, increasingly putting people at risk of dementia. About one in nine seniors has Alzheimer’s disease, the most common cause of the condition, which works out to some seven million Americans.”
“The long-awaited era of disease-modifying therapy for Alzheimer’s disease has finally arrived and will substantially impact how the disease is perceived and managed, although these new treatments will pose challenges for equitable access. The drugs closest to widespread clinical implementation are lecanemab and donanemab—intravenous monoclonal antibodies that remove β-amyloid plaques from the brain and can slow cognitive and functional decline.”
Donanemab appears to be the ‘easier’ choice. MMSE 20-28, Monthly Infusion (vs q2Wk), Stop when Amyloid PET is negative. Probably need to get APOE on these patients. https://doi.org/10.1016/S1474-4422(23)00274-0
Contact Dr. Varipapa’s office if you are interested in exploring this option.
CNMRI: Neurology, Sleep Medicine, MRI 