A groundbreaking advancement in Alzheimer's treatment offers new hope, as the U.S. Food and Drug Administration (FDA) has approved Donanemab, a drug marketed as Kisunla, for individuals in the early stages of the disease.
Kisunla manufactured by Eli Lilly could significantly slow cognitive decline in people with early symptomatic Alzheimer's disease, according to results of the company's clinical trials.
It is the second Alzheimer's drug that gets approval from the FDA followed by Eisai manufactured drug Leqembi which was approved last year.
Kisunla constitutes an antibody that works against the amyloid plaque buildup in the brain. It is approved for use in adults who have mild cognitive impairment and people in the mild dementia stage of Alzheimer's disease with confirmed amyloid accumulation in the brain.
In a trial conducted among more than 1,700 participants, Kisunla slowed cognitive and functional decline by up to 35% compared to placebo. It also reduced participants' risk of progressing to the next clinical stage of disease by up to 39%.
"Kisunla is the first and only amyloid plaque-targeting therapy that used a limited-duration treatment regimen based on amyloid plaque removal; nearly half of the study participants completed their course of treatment with Kisunla in 12 months. Once-monthly infusions of 30 minutes reduced amyloid plaques on average by 84% compared to the start of the study," a news release from Eli Lilly stated.
However, the patients should outweigh the risks vs benefits while taking the drug as experts caution against potentially dangerous side effects such as brain swelling and bleeding.
Although Kisunla and Leqembi both target amyloid buildup there are few differences between the two drugs. While Leqembi is given every two weeks, Kisunla involves once a month intravenous infusion. Another key difference is that Kisunla can be stopped once it clears all amyloid plaques from the brain.
In the trial, 17% of patients treated with Kisunla could stop the drug after six months; 47% stopped within a year; and 69% discontinued within 18 months. Notably, their cognitive decline continued to slow even after stopping the treatment.
"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," Dr. Howard Fillit, co-founder and chief science officer at the Alzheimer's Drug Discovery Foundation, said in the Lilly news release. "Diagnosing and treating Alzheimer's sooner than we do today has the potential to meaningfully slow disease progression, giving patients invaluable time to maintain their independence for longer."
The price of each vial of Kisunla is $695.65, with six-month treatment costing $12,522 and 12-month treatment costing $32,000.
