FDA Approves Lilly’s Alzheimer’s Disease Drug

The FDA has approved Eli Lily’s Kisunla (donanemab-azbt) to treat adults with early symptomatic Alzheimer’s disease (AD), which includes people with mild cognitive impairment and those with mild dementia.

Howard Fillit, M.D.

“This approval marks another step forward in evolving the standard of care for people living with Alzheimer's disease that will ultimately include an arsenal of novel treatments, providing much needed hope to the Alzheimer's community,” Howard Fillit, M.D., co-founder and chief science officer at the Alzheimer's Drug Discovery Foundation (ADDF), said in a news release.

"With the validation of new biomarkers, especially blood tests, we can now diagnose the disease with ease and intervene earlier than ever, including in the preclinical phase, opening the door preventio," he said. "We can finally deliver the right drugs to the right patients at the right time.”

Separately, the Alzheimer’s Association said in a statement that recent approvals generate hope for continued advances. “For researchers, our next horizon is to develop new treatments that address different components of the disease, and that work together to have an even bigger effect on slowing or stopping disease progression for all communities,” said Maria C. Carrillo, Ph.D., chief science officer and medical affairs lead, Alzheimer’s Association.

Alzheimer’s disease is a progressive disease caused by toxic amyloid proteins, and is the most common type of dementia, according to the Centers for Disease Control and Prevention. In 2020, about 5.8 million Americans were living with Alzheimer’s disease, and this number is projected to increase to 14 million by 2060.

Kisunla is a monoclonal antibody that targets the N3pG epitope present in brain amyloid plaques. It is available as a 350 mg/20 mL once-monthly injection for IV infusion. Lilly has priced Kisunla at $695.65 per vial, but the company noted in the news release that the total cost will vary by patient based on when they complete treatment.

Dosing instructions state that prescribers can consider stopping the dosing of Kisunla based on removal of amyloid plaques based on amyloid PET imaging. The company indicates that six months of treatment would have a total cost of $12,522. Additionally, 12 months of treatment with 13 infusions would cost $32,000 and 18 months of treatment with 19 infusions would cost $48,696.

Coverage and reimbursement for Kisunla are now available for eligible patients on Medicare under CMS’s National Coverage Determination with Coverage with Evidence Development. Also, as of October 2023, broad coverage and reimbursement for amyloid PET scans are available for eligible patients on Medicare. Lilly officials said that more than 98% of eligible Medicare patients have coverage that eliminates, limits, or caps their annual out-of-pocket exposure.

Lilly Support Services for Kisunla is a support program to help patients navigate treatment. The program includes offerings such as coverage determination assistance, care coordination, nurse navigator support, and customized support and resources.

Related: FDA Advisory Committee Supports Donanemab in Alzheimer’s Disease

Last month, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee members voted Monday 11 yes and 0 no on the question of whether Lilly’s donanemab is effective in treating patients with early symptomatic Alzheimer’s disease. They also voted 11 yes and 0 no on whether the benefits outweigh the risks of treatment with donanemab.

The approval was based on results of the phase 3 TRAILBLAZER-ALZ 2 trial, which evaluated the efficacy and safety of Kisunla in early symptomatic Alzheimer’s disease. Those treated with Kisunla who were less advanced in their disease showed a decline of 35% compared with placebo on the integrated Alzheimer's Disease Rating Scale, which measures memory, thinking, and daily functioning. Among the two groups analyzed, participants treated with Kisunla had up to a 39% lower risk of progressing to the next clinical stage of disease than those taking placebo.

Among the overall population of participants, Kisunla reduced amyloid plaques on average by 61% at 6 months, 80% at 12 months, and 84% at 18 months compared with the start of the study.

The data were shared at the 2023 Alzheimer’s Association International Conference and also published in the Journal of the American Medical Association.

Kisunla can cause amyloid-related imaging abnormalities (ARIA), which is a potential side effect with amyloid plaque-targeting therapies that does not usually cause symptoms. It can be detected via magnetic resonance imaging.