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US authorities have approved a new Alzheimer’s drug that may slow the disease somewhat, giving patients in the early stages of the incurable, memory-destroying disease a new option.
The Food and Drug Administration approved Eli Lilly’s Kisunla on Tuesday for mild to early cases of Alzheimer’s dementia. It is only the second drug to be convincingly shown to slow cognitive decline in patients, following the approval last year of a similar drug from Japanese pharmaceutical company Eisai.
The delay observed with both drugs is a matter of months – in the case of Lilly’s drug, about seven months.
Patients and their families will have to weigh the benefits against the risks, which include regular intravenous infusions and potentially dangerous side effects, such as brain swelling.
Doctors who treat Alzheimer’s say the approval is an important step after decades of failed experimental treatments.
“I’m glad I have different options to help my patients,” said Dr. Suzanne Schindler, a neurologist at Washington University in St. Louis.
“As a dementia specialist, it’s tough. I diagnose my patients with Alzheimer’s and every year I see their condition get worse and worse until they die.”
Slower decline
Both Kisunla and the Japanese drug Leqembi are lab-made antibodies, administered intravenously, that target one contributor to Alzheimer’s: the buildup of sticky amyloid plaque in the brain. Questions remain about which patients should receive the drugs and how long they might benefit.
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Approval of the new drug was expected after an outside panel of FDA advisers unanimously voted in favor of its benefits during a public meeting last month. That approval came despite several questions from FDA reviewers about how Lilly studied the drug, including allowing patients to stop treatment after their plaque reached very low levels.
The FDA approved Kisunla, known chemically as donanemab, based on the results of an 18-month study in which patients who received the treatment declined about 22 percent slower in terms of memory and cognitive abilities than patients who received a dummy infusion.
Kisunla and Leqembi are not listed in Health Canada’s database of drugs approved for use in this country.
The main safety concern was brain swelling and bleeding, a problem common to all plaque-targeting drugs. The rates reported in Lilly’s study — including 20 percent of patients with microbleeds — were slightly higher than those reported with rival Leqembi. However, the two drugs were tested in slightly different types of patients, making it difficult to compare the drugs’ safety, experts say.
Monthly infusion
Kisunla is administered once a month through an IV, while Leqembi needs to be administered twice a month. This can make it easier for caregivers who bring their loved ones to a hospital or clinic for treatment.
“It is certainly more attractive to have an infusion once a month than 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 low levels. More than 40 percent of patients stopped taking the drug after a year. Stopping the drug could reduce the costs and safety risks of long-term use. It’s not yet clear when patients should resume infusions.
Logistical hurdles, poor insurance coverage and financial concerns have all slowed the rollout of rival Leqembi, which Eisai is marketing with U.S. partner Biogen. Many smaller hospitals and health systems aren’t yet ready to prescribe the new plaque-targeting Alzheimer’s drugs.
First, doctors must confirm that dementia patients have the brain plaque targeted by the new drugs. Then they must 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 swelling or bleeding in the brain.
“These are all things that a physician has to have in place,” said Dr. Mark Mintun, who leads Lilly’s neuroscience division. “Until they’re in place, a patient who comes into their office is not going to be offered this therapy.”
Lilly has set the price of Kisunla at $695.65 per vial, which equates to $32,000 for 12 months of treatment.
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.
