Second Alzheimer’s drug approved by FDA

The new drug is able to modestly slow the disease.

The FDA has approved a new Alzheimer’s drug called Kisunla from Eli Lilly, which can modestly slow the progression of the disease in patients with mild or early dementia caused by Alzheimer’s.

This marks the second drug to convincingly show a delay in cognitive decline in Alzheimer’s patients, following the approval of a similar drug from Japanese drugmaker Eisai last year.


The big picture: The delay in cognitive decline with both drugs amounts to a matter of months, about seven months in the case of Lilly’s drug, and patients and their families will need to weigh the benefits against potential downsides such as regular IV infusions and side effects like brain swelling.

  • The approval of Kisunla is seen as an important step after decades of failed experimental treatments for Alzheimer’s, providing different options to help patients, according to Dr. Suzanne Schindler, a neurologist at Washington University in St. Louis.
  • The drug targets sticky amyloid plaque buildup in the brain, which is a contributor to Alzheimer’s, and questions remain about which patients should receive the drug and for how long they might benefit.

Driving the news: The approval of Kisunla was expected after an outside panel of FDA advisors voted in favor of its benefits, despite some questions about how Lilly studied the drug, including the allowance for patients to discontinue treatment after their plaque reached very low levels.

  • The cost of the therapy will vary by patient, with a year’s worth of therapy estimated to cost $32,000, higher than the price of the competitor drug from Eisai.
  • More than 6 million Americans have Alzheimer’s, but only those with early or mild disease will be eligible for the new drug, and an even smaller subset is likely to undergo the process needed to get a prescription.
  • The FDA approved Kisunla, also known as donanemab, based on an 18-month study in which patients receiving the treatment declined about 22% more slowly in terms of memory and cognitive ability than those who received a placebo infusion.
  • Brain swelling and bleeding are the main safety concerns associated with the drug, and logistical hurdles, spotty insurance coverage, and financial concerns have slowed the rollout of similar drugs in the past.
  • Lilly’s drug has the potential advantage of being infused once a month compared to the twice-a-month regimen of the competitor drug, providing potential benefits for both patients and caregivers.
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