FDA approves second Alzheimer’s drug that may slightly slow progression

WASHINGTON (AP) — U.S. officials have approved one other Alzheimer’s Disease Cure which may slightly slow down the progression of the disease, providing a brand new option for patients within the early stages an incurable disease that destroys memory.

The Food and Drug Administration on Tuesday approved Eli Lilly’s drug Kisunla for mild or early cases of dementia attributable to Alzheimer’s disease. It’s just second medicine which has been convincingly proven to delay cognitive decline in patients, following approval last 12 months similar medicine from Japanese drug manufacturer Eisai.

The delay seen with each drugs is several months — about seven months for Lilly’s. Patients and their families might want to weigh that profit against the drawbacks, which include regular intravenous infusions and potentially dangerous unwanted side effects like brain swelling.

Alzheimer’s doctors say the drug’s approval is a vital step after many years of failed experimental treatments.

“I’m excited to have options to help my patients,” said Dr. Suzanne Schindler, a neurologist at Washington University in St. Louis. “As a dementia specialist, it was tough — I would diagnose my patients with Alzheimer’s and then watch them get worse and worse every year until they died.”

Both Kisunla and the Japanese drug, this group, are lab-made antibodies, administered intravenously, that goal a single contributing factor to Alzheimer’s—the sticky amyloid plaque that builds up within the brain. Questions remain about which patients should receive the drugs and the way long they could provide profit.

Approval of the brand new drug was expected after an out of doors panel of FDA advisers voted unanimously in favor of its advantages at a public meeting last month. That endorsement got here despite several questions from FDA reviewers about how Lilly studied the drug, including allowing patients to stop treatment once their plaques reached very low levels.

Costs will vary from patient to patient, depending on how long they take the drug, Lilly said. The company also said a 12 months of therapy will cost $32,000 — greater than the $26,500 price tag for a 12 months of Leqembi.

The FDA leaflet says doctors may consider stopping the drug after brain scans confirm that patients have minimal plaque.

More than 6 million Americans have Alzheimer’s. Only those with early or mild disease will probably be eligible for the brand new drug, and a good smaller group is prone to undergo the multi-step process required to get a prescription.

The Food and Drug Administration (FDA) approved Kisunla, known by its chemical name donanemab, based on results from an 18-month study wherein patients given the drug had a few 22% slower decline in memory and cognition than those given a sham infusion.

The primary safety issue was brain swelling and bleeding, a standard problem in all dental plaque medicationsThe rates reported within the Lilly study — which included 20% of patients with microbleeds — were slightly higher than those reported for the competing drug Leqembi. But the 2 drugs were tested in slightly several types of patients, which experts say makes it difficult to check the drugs’ safety.

Kisunla is run once a month, while Leqembi is run twice a month. This could make life easier for caregivers who bring their family members to the hospital or clinic for treatment.

“Of course, an infusion once a month is more attractive than every two weeks,” Schindler said.

Featured Stories

Lilly’s drug has one other potential advantage: Patients can stop taking it in the event that they respond positively.

In the corporate’s study, patients were weaned off Kisunli when their brain plaques reached nearly undetectable levels. Almost half of patients reached that point inside a 12 months. Stopping the drug could reduce the prices and safety risks of long-term use. It’s not yet clear how soon patients might have to restart the infusions.

Logistical obstacles, uncertain insurance and financial concerns made slowed down the implementation competitor Leqembi, which Eisai co-markets with U.S. partner Biogen. Many smaller hospitals and health systems aren’t yet prepared to prescribe the brand new Alzheimer’s drugs that goal atherosclerotic plaques.

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

“That’s all a doctor needs to have,” said Dr. Mark Mintun, head of neurology at Lilly. “Until they get used to it, the patient who comes into their office won’t be offered that therapy.”