In a glimmer of hope for millions battling Alzheimer's, the FDA granted approval to Eli Lilly's Donanemab, known commercially as Kisunla.
Alzheimer's, the leading cause of dementia, afflicts nearly 7 million Americans, with projections suggesting a staggering rise in the coming decades. Kisunla's approval provides a much-needed option for patients in the early stages of the disease.
"This is real progress," said Joanne Pike, CEO of the Alzheimer's Association. Time has been a cruel companion for those battling this disease, and Kisunla offers a chance for more time and potentially a slower decline. The ability for doctors to offer multiple treatment options is a major advancement.
The FDA initially rejected Kisunla in 2023 due to data concerns, followed by another delay in March. However, an advisory panel ultimately recommended approval in June, highlighting the drug's potential benefits despite some risks.
Kisunla joins Leqembi, a similar treatment approved last year, in offering a new approach to Alzheimer's. Both drugs target the buildup of amyloid plaque, a hallmark of the disease, with the goal of slowing its progression. Studies show Kisunla reduced Alzheimer's progression by 35% over 18 months compared to a placebo.
Administered through monthly infusions, Kisunla's pricing varies depending on treatment duration. While insurance coverage is available, the cost can be substantial, ranging from over $12,000 for a six-month course to nearly $50,000 for 18 months.
It's important to note that Kisunla, like other drugs targeting amyloid plaques, carries potential safety risks. These include serious side effects like brain swelling and bleeding. Tragically, three patients died from these complications during Kisunla's trials.
Kisunla's approval is the third for this type of drug, following Leqembi and the recently discontinued Aduhelm. Aduhelm's approval in 2021 was met with controversy due to concerns about its effectiveness.
Despite these challenges, Kisunla's arrival signifies undeniable progress.
* Israel HaYom contributed to this article.
