In a significant development, the U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s new Alzheimer’s medication, Kisunla (donanemab), marking the second treatment available in the country for slowing the progression of this debilitating disease.
The approval of Kisunla comes after clinical trials demonstrated its ability to moderately decelerate the decline in memory and cognitive functions in individuals with early-stage Alzheimer’s or mild cognitive impairment. The drug, administered through monthly infusions, targets the accumulation of amyloid plaque in the brain, a hallmark of Alzheimer’s disease.
“This approval marks a pivotal moment in the fight against Alzheimer’s disease, offering hope to patients and their families,” said Forbes in its coverage of the FDA’s decision. The approval was based on a comprehensive trial involving 1,700 participants, which showed a 35% reduction in the progression of Alzheimer’s compared to a placebo over 18 months.
Kisunla, priced at $32,000 for a year’s supply, is expected to be covered by Medicare, with a 20% coinsurance for patients after meeting their deductible. This aligns with a recent policy to fund FDA-approved Alzheimer’s drugs, though with a requirement for monitoring real-world effectiveness data.
While Kisunla presents a promising treatment option, it carries potential life-threatening side effects, including brain swelling and bleeding. Eli Lilly anticipates that patients may discontinue treatment once amyloid levels decrease substantially, with a possibility of needing to resume treatment if amyloid reappears.
The approval of Kisunla comes on the heels of the FDA’s approval of Leqembi, another Alzheimer’s drug, in 2023. These advancements in Alzheimer’s treatment offer new hope for patients and their families, as the prevalence of the disease is expected to rise significantly in the coming years.
“The Alzheimer’s Association hailed the approval of the treatment as a significant milestone, offering patients more options and increased chances of prolonging their quality of life,” reported CNN. As the battle against Alzheimer’s disease continues, the availability of these new treatments underscores the ongoing efforts to address this critical public health concern.