The FDA approves a second Alzheimer’s drug that may modestly slow the disease: NPR

WASHINGTON – US officials have approved another Alzheimer’s drug that could modestly slow the disease, offering a new option for patients in the early stages of the incurable, memory-destroying disease.

The Food and Drug Administration approved Eli Lilly’s Kisunla on Tuesday for mild or early cases of dementia caused by Alzheimer’s. It is only the second drug to be convincingly shown to delay cognitive decline in patients, following the approval last year of a similar drug by Japanese manufacturer Eisai.

The first delay with both drugs is several months — about seven months, in the case of the Lilly 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.

Doctors who treat Alzheimer’s say the approval is an important step after decades of failed experimental treatments.

“I am excited 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 deteriorate and progress until they die.”

Both Kisunla and the Japanese drug, Leqembi, are lab-made antibodies administered by IV that target a contributor to Alzheimer’s — the accumulation of sticky amyloid plaques in the brain. Questions remain about which patients should receive the drugs and for how long they can benefit.

Approval of the new drug was expected after an outside panel of FDA advisers voted unanimously in favor of its benefits at a public meeting last month. That approval came despite some questions from FDA reviewers about how Lilly studied the drug, including allowing patients to stop 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 tag of a year’s worth of Leqembi.

The FDA’s prescribing information tells doctors they can consider stopping the drug after confirming through brain scans that patients have minimal plaque.

More than 6 million Americans have Alzheimer’s. Only those with early or mild disease will qualify for the new drug, and an even smaller subset will likely 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 who received the treatment declined about 22% more slowly in memory and cognitive ability than those who received a dummy infusion.

The main safety issue was brain swelling and bleeding, a common problem with 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 injected once a month compared to Leqembi’s twice-monthly 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 attractive 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 after their brain plaque reached nearly undetectable levels. Almost half of the patients reached that point within a year. Discontinuing the drug can reduce the costs and safety risks of long-term use. It is not yet clear how soon patients may need to resume infusions.

Logistical hurdles, tainted insurance coverage and financial concerns have all slowed the rollout of competitor Leqembi, which Eisai co-brands with US partner Biogen. Many smaller hospitals and health systems are not yet set up to prescribe the new plaque-targeting Alzheimer’s drugs.

First, doctors need to confirm that dementia patients have the plaque in the brain targeted by the new drugs. Then they must find a drug infusion center where patients can receive therapy. Meanwhile, nurses and other staff should be trained to perform repeated scans to check for brain swelling or bleeding.

“These are all things that a doctor should have decided,” said Dr. Mark Mintun, who heads Lilly’s neuroscience division. “Until they get used to them, a patient coming into his office won’t be offered this therapy.”