![This image provided by Eli Lilly shows the company's new Alzheimer's treatment Kisunla. The Food and Drug Administration approved Eli Lilly's Kisunla on Tuesday for mild to early dementia due to Alzheimer's.](https://npr.brightspotcdn.com/dims3/default/strip/false/crop/3000x2000+0+0/resize/1100/quality/85/format/jpeg/?url=http%3A%2F%2Fnpr-brightspot.s3.amazonaws.com%2Ffa%2F56%2Feeeab5324cfda41b2715edbcf10e%2Fap24184513211915.jpg)
This image provided by Eli Lilly shows the company's new Alzheimer's treatment Kisunla. The Food and Drug Administration approved Eli Lilly's Kisunla on Tuesday for mild to early dementia due to Alzheimer's.
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WASHINGTON — U.S. officials have approved another drug that can slightly slow the progression of Alzheimer's disease, providing a new option for patients in the early stages of the otherwise incurable and memory-destroying disease.
The Food and Drug Administration on Tuesday approved Eli Lilly's Kisunla for mild to early dementia due to Alzheimer's disease, the second drug to be convincingly shown to slow cognitive decline in patients, following the approval of a similar drug from Japanese drugmaker Eisai last year.
The delay seen with both drugs is several months—about seven months for Lilly. Patients and their families must weigh the benefits against the downsides, including regular IV infusions and potentially dangerous side effects such as brain swelling.
Doctors who treat Alzheimer's disease say the approval is a major advance after decades of failed experimental treatments.
“I’m glad there are so many options to help patients,” said Dr. Susan Schindler, a neurologist at Washington University in St. Louis. “It’s been a challenge as a dementia specialist. I diagnose patients with Alzheimer’s disease and then watch it get worse and worse every year until they die.”
![Colorful pieces of trash, including plastic bottle caps and plastic forks, are arranged in the shape of a human brain on a bright blue background.](https://npr.brightspotcdn.com/dims3/default/strip/false/crop/4000x4000+1000+0/resize/100/quality/100/format/jpeg/?url=http%3A%2F%2Fnpr-brightspot.s3.amazonaws.com%2F03%2Ffb%2F46e24c4143f9a160886f33fab223%2Fgettyimages-1316416906.jpg)
Kisunla and the Japanese drug Leqembi are both lab-made antibodies that are given by IV and target the sticky amyloid plaques that build up in the brain, a factor in Alzheimer's disease. Questions remain about which patients should take the drugs and how long they will benefit.
The new drug’s approval was expected after an outside panel of FDA advisors unanimously endorsed the drug’s benefits at a public meeting last month. The endorsement came despite several questions from FDA reviewers about how Lilly studied the drug, including allowing patients to stop treatment after their plaque levels reached very low levels.
Lilly said the cost varies depending on how long a patient takes the drug. The company also said a one-year treatment would cost $32,000, which is higher than the $26,500 price tag for a one-year Leqembi.
The FDA prescribing information states that doctors can stop taking the drug after a brain scan shows that a patient's plaques have been minimally reduced.
More than 6 million Americans have Alzheimer's disease. Only those with early or mild disease will be able to use the new drug, and an even smaller subset of people will likely have to go through the multi-step process required to get a prescription.
The FDA approved Keysunra, known chemically as donanemab, after an 18-month study that found that patients who received the treatment declined about 22 percent more slowly in memory and cognitive abilities than those who received a sham infusion.
The main safety concerns were brain swelling and bleeding, which are common problems with all plaque-targeting drugs. The rates reported in Lilly’s study (including 20% of patients with microbleeds) were slightly higher than those reported for rival drug Rekembi. But experts say it’s hard to compare the safety of the drugs because the two drugs were tested in slightly different types of patients.
Keysunra is given as a once-a-month injection, unlike Rekembi, which is given twice a month. This may make things easier for caregivers who bring their loved ones to the hospital or clinic for treatment.
“Certainly, getting an injection once a month is more appealing than getting an injection once every two weeks,” Schindler said.
Lilly's drug has another potential advantage: If patients respond well, they can stop taking it.
In the company’s study, patients stopped taking Kisunla when their brain plaques reached nearly undetectable levels. Nearly half of patients reached that point within a year. Stopping the drug could reduce the cost and safety risks of long-term use. It’s not yet clear how soon patients should resume infusions.
Logistical hurdles, shaky insurance coverage and financial concerns have delayed the launch of rival Leqembi, which Eisai is co-marketing with U.S. partner Biogen. Many smaller hospitals and health systems aren’t ready to prescribe new plaque-targeting Alzheimer’s drugs yet.
First, doctors must determine whether the dementia patient has the brain plaques that the new drugs target. Then they must find a drug infusion center where the patient can receive the treatment. Meanwhile, nurses and other staff must be trained to perform repeated scans to check for brain swelling or bleeding.
“These are all things that the doctor has to set up,” says Dr. Mark Mintun, who leads Lilly’s neuroscience division. “Until patients are comfortable with it, it’s not going to be offered to patients coming into the office.”