In a significant development, U.S. officials have greenlit another Alzheimer's drug that shows promise in slowing the progression of the disease.
The Food and Drug Administration gave the nod to Eli Lilly's new medication, Kisunla , on Tuesday. The medication targets mild or early dementia caused by Alzheimer's by helping to remove 'plaque' from the brain that causes the memory problems and mental fog.
This marks only the second instance where a drug has been proven to decelerate cognitive deterioration, hot on the heels of last year's sanctioning of a similar medication from Japanese pharmaceutical company Eisai. The new medication offers hope to patients grappling with the early stages of this relentless memory-eroding condition .
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The postponement in cognitive decline offered by both drugs is modest approximately seven months for Lilly's treatment. Patients and their loved ones are now faced with considering the value of this limited time against the drawbacks, which include the need for ongoing IV infusions and the risk of serious adverse effects such as brain swelling.
Alzheimer's specialists welcome the FDA's approval as a critical advancement following numerous unsuccessful trials spanning decades. "I'm thrilled to have different options to help my patients," expressed Dr. Suzanne Schindler, a neurologist at Washington University in St. Louis.
"It's been difficult as a dementia specialist - I diagnose my patients with Alzheimer's and then every year I see them get worse and they progress until they die."
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Both Kisunla and the Japanese drug Leqembi are lab-created antibodies, administered via IV, that target one contributor to Alzheimer's - sticky amyloid plaque buildup in the brain. There are still questions about which patients should receive the drugs and for how long they might benefit.
The new drug's approval was anticipated after an external panel of FDA advisors unanimously voted in favor of its benefits at a public meeting last month. This endorsement came despite several queries from FDA reviewers about Lilly's study of the drug, including allowing patients to stop treatment once their plaque reached very low levels.
Lilly stated that costs will vary per patient, depending on how long they take the drug. The company also revealed that a year's worth of therapy would cost $32,000 - higher than the $26,500 price tag of a year's worth of Leqembi.
The FDA's prescribing information advises doctors to consider discontinuing the drug after confirming through brain scans that patients have minimal plaque.
The FDA approved Kisunla, known chemically as donanemab, based on results from an 18-month study where patients given the treatment declined about 22% more slowly in terms of memory and cognitive ability than those who received a placebo infusion.
The main safety concern with the Alzheimer's drug Kisunla is brain swelling and bleeding, a side effect seen in all plaque-targeting medications. Lilly's study reported slightly higher rates of these issues, including 20% of patients experiencing microbleeds, compared to its rival Leqembi.
However, experts caution against direct comparisons due to differences in patient groups between the studies.
Kisunla offers a more convenient dosing schedule, requiring only a monthly infusion, which could be a relief for caregivers accustomed to more frequent hospital visits for treatments like Leqembi's bi-monthly regimen.
"Certainly getting an infusion once a month is more appealing than getting it every two weeks," commented Schindler on the subject.
Another potential benefit of Lilly's drug is the option to discontinue use after successful reduction of brain plaque. In the study, patients stopped receiving Kisunla when their brain plaque levels were sufficiently lowered, potentially cutting costs and long-term safety risks.
The timing for when or if patients might need to restart treatment remains uncertain. Leqembi's market introduction has been hampered by logistical challenges, inconsistent insurance coverage, and financial worries. Many smaller hospitals and health systems have yet to establish protocols for prescribing these new Alzheimer's treatments that target brain plaque.
First, doctors must confirm that patients with dementia have the targeted brain plaque for the new drugs. Then, locating a drug infusion center for patient therapy is next in line.
At the same time, it is crucial for nurses and support staff to be trained to carry out repeated scans for brain swelling or bleeding.
"Those are all things a physician has to have set up," Dr. Mark Mintun of Lilly's neuroscience division stated. "Until they get used to them, a patient who comes into their office will not be offered this therapy."
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