FDA Approves Second Alzheimer’s Drug That May Modestly Slow the Disease

WASHINGTON – US officials approved another Alzheimer’s medication which may modestly slow the disease, providing a new option for patients in the early stages of incurable disease that destroys memory.

The Food and Drug Administration approved Eli Lilly’s Kisunla on Tuesday for mild or early cases of dementia caused by Alzheimer’s disease. It’s just the second drug which has been convincingly shown to slow cognitive decline in patients, following the approval last year of a similar drug from Japanese pharmaceutical company Eisai.

The delay seen with both medications is a matter of months – about seven months in the case of Lilly’s medication. Patients and their families will have to weigh this benefit against the drawbacks, including regular intravenous infusions and potentially dangerous side effects such as brain swelling.

Doctors who treat Alzheimer’s disease 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 every year I see them getting worse and progressing until they die.”

Both Kisunla and the Japanese drug, Leqembi, are laboratory-produced antibodies, administered intravenously, that target a contributor to Alzheimer’s disease – the buildup of sticky amyloid plaque in the brain. Questions remain about which patients should receive the drugs and for how long they will benefit.

Approval of the new drug was expected after an external panel of FDA advisers voted unanimously in favor of its benefits at a public meeting last month. That endorsement came despite multiple questions from FDA reviewers about how Lilly studied the drug, including allowing patients to stop treatment after plaque reached very low levels.

Costs vary by patient, based on how long they take the medication, Lilly said. The company also said a year of therapy would cost $32,000 — higher than Leqembi’s $26,500 price tag for a year.

The FDA’s prescribing information tells doctors that they may consider discontinuing 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 be eligible for the new drug, and an even smaller subset will likely go through the multi-step process required to obtain a prescription.

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% more slowly in terms of memory and cognitive ability than those who received an infusion. simulated.

The main safety issue was brain swelling and bleeding, a problem common to all plaque-targeted medications. The rates reported in the Lilly study – including 20% ​​of patients with microbleeds – were slightly higher than those reported with competitor Leqembi. However, the two drugs were tested on 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 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 removed from Kisunla when brain plaque reached nearly undetectable levels. Nearly half of patients reached this point within a year. Stopping the medication can reduce the costs and safety risks of long-term use. It’s not yet clear when patients might need to resume infusions.

Logistical hurdles, spotty insurance coverage and financial concerns delayed the launch from competitor Leqembi, which Eisai markets in partnership with North American partner Biogen. Many hospitals and smaller health systems are not yet ready to prescribe the new Alzheimer’s drugs that fight plaques.

First, doctors need to confirm whether dementia patients 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 examinations to check for brain swelling or bleeding.

“These are all things a doctor needs to set up,” said Dr. Mark Mintun, who heads Lilly’s neuroscience division.

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