The U.S. Food and Drug Administration has approved Kisunla, a groundbreaking treatment for early-stage Alzheimer’s disease created by Eli-Lilly, according to a press release from the company.
Kisunla, administered as a monthly intravenous injection, targets adults with mild cognitive impairment or early-stage dementia linked to Alzheimer’s.
What sets this drug apart is its unique approach: it’s the first therapy to directly target and remove amyloid plaques in the brain, a hallmark of Alzheimer’s disease.
Clinical trials have shown promising results.
Patients receiving Kisunla experienced up to 35% less cognitive and functional decline over 18 months compared to those on a placebo.
Breaking News: The FDA has granted approval of Kisunla (donanemab) for the treatment of people living with early symptomatic Alzheimer’s disease. We celebrate Kisunla’s approval, as more treatment options mean a greater opportunity for #MoreTime. https://t.co/vBTSicKyZ4
— Alzheimer's Association (@alzassociation) July 2, 2024
Moreover, the drug reduced amyloid plaques by an average of 84% from baseline levels.
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Anne White, executive vice president at Eli Lilly, emphasized the drug’s potential impact: “Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options.”
One of Kisunla’s most intriguing features is its potential for a finite treatment course.
Nearly half of the study participants completed their treatment within 12 months, suggesting that the drug might not require lifelong administration.
This aspect could have significant implications for both patient care and healthcare costs.
The FDA has now approved donanemab, trade name Kisunla, an anti-amyloid antibody, for treatment of early-stage Alzheimer’s. This treatment does not improve cognition, but slows decline by 35%. Side effects include brain bleeding, brain swelling, and in three cases, death. pic.twitter.com/k0wdtpNelU
— Dr. Dale Bredesen (@DrDaleBredesen) July 2, 2024
Dr. Howard Fillit from the Alzheimer’s Drug Discovery Foundation praised the approval, noting, “This approval marks another step forward in evolving the standard of care for people living with Alzheimer’s disease.” He highlighted the potential for reduced out-of-pocket costs and infusion burden for eligible patients.
While exact pricing details are yet to be disclosed, industry analysts are closely watching how Eli Lilly will position Kisunla in the market. The drug’s pricing strategy could set a precedent for future Alzheimer’s treatments and impact Eli Lilly’s revenue projections.
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Additionally, doctor’s ability to diagnose Alzheimer’s early enough for Kisunla to be most effective will be a critical factor in the drug’s success.
