The US Food and Drug Administration (FDA) has granted approval to Eli Lilly's Alzheimer's drug Donanemab, marketed as Kisunla, marking a significant advancement in the treatment of early symptomatic Alzheimer's disease. This decision, announced on Tuesday, adds a promising option to the limited arsenal of treatments available for this devastating condition.
Hope for Alzheimer's? FDA approves Eli Lilly's groundbreaking treatmenthttps://t.co/Nf4x1w2o0t#AlzheimersDisease #Lilly #UnitedStates #FDA pic.twitter.com/V8mHIIapsK
— Israel Hayom English (@IsraelHayomEng) July 3, 2024
Alzheimer's disease, the fifth-leading cause of death for adults over 65, affects nearly 7 million Americans, with projections indicating a rise to almost 13 million by 2050. The approval of Kisunla represents a beacon of hope for patients and their families grappling with this challenging illness.
Joanne Pike, president and CEO of the Alzheimer's Association, expressed enthusiasm about the FDA's decision. "This is real progress. Today's approval allows people more options and greater opportunity to have more time," Pike stated. "Having multiple treatment options is the kind of advancement we've all been waiting for — all of us who have been touched, even blindsided, by this difficult and devastating disease."
Kisunla faced several challenges on its way to FDA approval. The FDA initially rejected the drug last year due to insufficient data and unexpectedly delayed it again in March. However, in June, an advisory panel to the agency recommended the treatment for full approval, concluding that its benefits outweigh the risks.
Kisunla will compete directly with Leqembi, a treatment developed by Biogen and its Japanese partner Eisai, which received approval last summer. Both drugs represent significant milestones in Alzheimer's treatment after three decades of unsuccessful attempts to develop effective medicines against the disease.
These treatments are monoclonal antibodies targeting toxic amyloid plaques in the brain, a hallmark of Alzheimer's. They aim to slow the progression of the disease in its early stages. In a late-stage trial, Kisunla demonstrated a 35% reduction in Alzheimer's progression over 18 months compared to a placebo.
Administered through monthly infusions, Kisunla's pricing structure varies based on treatment duration. A six-month course is estimated at $12,522, while 12 and 18-month treatments are priced at $32,000 and $48,696, respectively. Eli Lilly has confirmed that Medicare coverage and reimbursement will be available for eligible patients.
It's crucial to note that while these treatments offer hope, they are not cures. Drugs targeting amyloid plaques can have significant safety risks, including potentially severe brain swelling and bleeding, known as amyloid-related imaging abnormalities (ARIA). In Kisunla's late-stage trial, three patients tragically died from severe forms of these side effects.
The approval of Kisunla marks the third drug of its kind to reach the market, following Leqembi and Aduhelm, another treatment from Biogen and Eisai. However, Aduhelm was recently discontinued following controversy surrounding its expedited FDA approval in 2021 despite a negative recommendation from an advisory panel.
As the landscape of Alzheimer's treatment continues to evolve, the approval of Kisunla offers renewed hope for millions affected by this debilitating disease. While challenges remain, this development signifies progress in the ongoing battle against Alzheimer's and paves the way for future advancements in treatment options.
