The second drug that slows Alzheimer’s disease has been approved for use in the US

US officials have approved a second Alzheimer’s drug that can modestly slow the disease, offering a new option for patients in the early stages. The Food and Drug Administration on Tuesday approved Eli Lilly’s Kisunla for mild or early cases of Alzheimer’s dementia.

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 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 the benefit 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 an important step after decades of failed experimental treatments. “I’m excited to have different options to help my patients,” said Dr. Suzanne Schindler, a neurologist at Washington University in St. Louis.

“It was difficult as a dementia specialist – I diagnose my patients with Alzheimer’s and then every year I see them get worse and progress until they die.”

Both Kisunla and the Japanese drug, Leqembi, are lab-made antibodies given by IV that target a contributor to Alzheimer’s — the buildup of sticky amyloid plaques in the brain. Questions remain about which patients should receive the drugs and how long they might 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 several 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 depending on how long they take the drug, Lilly said. The company also said a year’s worth of therapy would cost $32,000 (£25,256), higher than Leqembi’s $26,500 price tag for a year.

The FDA’s prescribing information tells doctors they can consider stopping the drug after confirming through brain scans that patients have minimal plaque. 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 more slowly in memory and cognitive ability than those who did not. who were given an inactive infusion.

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 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 administered 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 appealing than every two weeks,” Dr. 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 a low level. Discontinuing the drug could reduce the costs and safety risks of long-term use. It is not yet clear when patients may need to resume infusions.