WASHINGTON (AP) — U.S. officials have approved another Alzheimer’s drug that can modestly slow the disease, providing a new option for patients in the early stages of the incurable, memory-destroying ailment.
The Food and Drug Administration approved Eli Lilly’s Kisunla on Tuesday for mild or early cases of dementia caused by Alzheimer’s. It’s only the second drug that’s been convincingly shown to delay cognitive decline in patients, following last year’s approval of a similar drug from Japanese drugmaker Eisai.
The delay seen with both drugs amounts to a matter of months — about seven months, in the case of Lilly’s drug. Patients and their families will have to weigh that benefit against the downsides, including regular IV infusions and potentially dangerous side effects like brain swelling.
Physicians who treat Alzheimer’s say the approval is an important step after decades of failed experimental treatments.
“I’m thrilled to have different options to help my patients,” said 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.”
Both Kisunla and the Japanese drug, Leqembi, are laboratory-made antibodies, administered by IV, that target one contributor to Alzheimer’s — sticky amyloid plaque buildup in the brain. Questions remain about which patients should get the drugs and how long they might benefit.
The new drug’s approval was expected after an outside panel of FDA advisors unanimously voted in favor of its benefits at a public meeting last month. That endorsement came despite several questions from FDA reviewers about how Lilly studied the drug, including allowing patients to discontinue treatment after their plaque reached very low levels.
Costs will vary by patient, based on how long they take the drug, Lilly said. The company also said a year’s worth of therapy would cost $32,000 — higher than the $26,500 price of a year’s worth of Leqembi.
The FDA’s prescribing information tells doctors they can consider stopping the drug after confirming via brain scans that patients have minimal plaque.
More than 6 million Americans have Alzheimer’s. Only those with early or mild disease will be eligible for the new drug, and an even smaller subset are likely to undergo the multi-step process needed to get a prescription.
The FDA approved Kisunla, known chemically as donanemab, based on results from an 18-month study in which patients given getting the treatment declined about 22% more slowly in terms of memory and cognitive ability than those who received a dummy infusion.
The main safety issue was brain swelling and bleeding, a problem common to all plaque-targeting drugs. The rates reported in Lilly’s study — including 20% of patients with microbleeds — were slightly higher than those reported with competitor Leqembi. However, the two drugs were tested in slightly different types of patients, which experts say makes it difficult to compare the drugs’ safety.
Kisunla is infused once a month compared to Leqembi’s twice-a-month regimen, which could make things easier for caregivers who bring their loved ones to a hospital or clinic for treatment.
“Certainly getting an infusion once a month is more appealing than getting it every two weeks,” Schindler said.
Lilly’s drug has another potential advantage: Patients can stop taking it if they respond well.
In the company’s study, patients were taken off Kisunla once their brain plaque reached nearly undetectable levels. Almost half of patients reached that point within a year. Discontinuing the drug could reduce the costs and safety risks of long-term use. It’s not yet clear how soon patients might need to resume infusions.
Logistical hurdles, spotty insurance coverage and financial concerns have all slowed the rollout of competitor Leqembi, which Eisai co-markets with U.S. partner Biogen. Many smaller hospitals and health systems aren’t yet setup to prescribe the new plaque-targeting Alzheimer’s drugs.
First, doctors need to confirm that patients with dementia have the brain plaque targeted by the new drugs. Then they need to find a drug infusion center where patients can receive therapy. Meanwhile, nurses and other staff must be trained to perform repeated scans to check for brain swelling or bleeding.
“Those are all things a physician has to have set up,” said Dr. Mark Mintun, who heads Lilly’s neuroscience division. “Until they get used to them, a patient who comes into their office will not be offered this therapy.”
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
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Rephrased content:
U.S. officials have given the green light for the use of a new Alzheimer’s drug named Kisunla, developed by Eli Lilly, that could slightly slow the progress of the disease, offering a fresh treatment choice for individuals in the early stages of this memory-robbing condition. This approval marks the second time a drug has been proven to delay cognitive decline in Alzheimer’s patients, following the approval of a similar drug by Japanese drugmaker Eisai last year.
Although the delay in cognitive decline with the use of both drugs is modest, about seven months with Lilly’s Kisunla, patients and their families must consider this benefit alongside potential downsides, such as regular IV infusions and risks like brain swelling.
Physicians specializing in Alzheimer’s treatment view this approval as a significant advancement after years of unsuccessful experimental treatments. The approval signifies an essential milestone for healthcare professionals working with dementia patients, offering them different options to assist their patients.
Both Kisunla and the Japanese drug Leqembi are artificially created antibodies administered through IV that target a key contributor to Alzheimer’s disease – the accumulation of sticky amyloid plaque in the brain. However, uncertainties remain about which patients would benefit most from these drugs and the duration of their effectiveness.
The FDA’s approval of the new drug was anticipated following a unanimous vote by an outside panel of FDA advisors endorsing its benefits during a public meeting last month. The approval came despite some concerns raised by FDA reviewers about how Lilly conducted the drug’s study.
The cost of the treatment will vary depending on the duration of use. Lilly stated that a year’s supply of therapy would be priced at $32,000, slightly higher than the cost of a year’s worth of Leqembi at $26,500.
It is important to note that more than 6 million Americans are affected by Alzheimer’s disease. The new drug, Kisunla (donanemab), was approved based on an 18-month study demonstrating that patients who received the treatment experienced a 22% slower decline in memory and cognitive function compared to those who received a placebo infusion.
A primary safety concern associated with the drug was brain swelling and bleeding, common side effects of drugs targeting plaque in the brain. However, the safety profile of Kisunla might differ from that of Leqembi since the drugs were tested on slightly different patient populations.
Kisunla’s infusion schedule of once a month, as opposed to Leqembi’s bi-monthly regimen, could offer a more convenient treatment option for caregivers. Moreover, the possibility of patients discontinuing Kisunla once their brain plaque levels decrease significantly may reduce long-term costs and safety risks.
Despite the approval of these new plaque-targeting Alzheimer’s drugs, logistical challenges, limited insurance coverage, and financial considerations have slowed down their implementation. Many healthcare facilities are not yet equipped to prescribe these new treatments, and specific infrastructure and training are required before patients can receive the therapy.
Dr. Mark Mintun, who leads Lilly’s neuroscience division, emphasizes the importance of healthcare providers being familiar with the necessary procedures and protocols to offer these treatments, as this would directly impact patients’ access to this innovative therapy.
