Ash Ponders / The New York Times
Bev Krol, who has been a participant in a trial for the drug donanemab for nearly three years, with her husband, Mark, at Banner Alzheimer’s Institute in Phoenix, June 29, 2024. The drug, Kisunla, made by Eli Lilly, is the latest in a new class of treatments that could modestly slow cognitive decline in initial stages of the disease but also carry safety risks.
Friday, July 5, 2024 | 2 a.m.
For Dr. Jeffrey Cummings, a brain health researcher and professor at UNLV, this is an exciting time in the fight against Alzheimer’s disease.
Federal health advisers in May voted to back an Alzheimer’s drug from Eli Lilly and Co. that can slow the progression of cognitive decline and memory problems. On Tuesday morning the drug — donanemab — gained final approval from the U.S. Food and Drug Administration, making it the second Alzheimer’s drug that slows cognitive decline cleared for use in the United States.
The approval brings about a hopeful age for Alzheimer’s research after almost two decades of drought, said Cummings who has been involved with Alzheimer’s research for nearly four decades.
“We’ve just entered a brand new era in Alzheimer’s disease research based on our ability to manipulate the disease successfully,” Cummings said. “It took a long time to get to this exciting point.”
The professor has watched the industry grow from the first drug approval in 1993 to an “unbelievable period” today. Alzheimer’s disease was recorded as early as 1906, Cummings said, but the influx of research didn’t happen until the early 2000s.
Between 1993 and 2004, five drugs to address Alzheimer’s disease won FDA approval, but there wasn’t another approval from 2004 to 2021, despite $44.5 billion being invested in drug development during that time, Cummings said.
A new antibody treatment drug, aducanumab, or Aduhelm, which uses the immune system to remove toxic proteins in the brain, was approved in 2021 for Alzheimer’s patients. Aduhelm, however, was discontinued by Biogen, its manufacturer, this year.
Lequembi, also known as lecanemab and manufactured by Japanese drugmaker Eisai, was approved in early 2023 as the first-ever disease-modifying therapies to earn a passing grade from the FDA.
Lilly’s new drug — which will be sold under the name Kisunla — now joins the list.
Each vial of Kisunla will cost $695.65, with a six-month treatment duration costing $12,522 for the 30-minute, once-a-month infusions, according to Eli Lilly. Patients can get limited-duration treatments for six, 12 or 18 months, so the total cost will vary based on when they complete that treatment.
Lilly said in May that donanemab appeared to work in slowing the progression of cognitive decline and memory loss in patients by targeting amyloid plaque buildup in the brain — one of the main causes of Alzheimer’s disease, The Associated Press reported.
The company conducted a study of 1,700 patients ages 60 to 85 who were in the early stages of Alzheimer’s, with half receiving once-a-month infusions of donanemab and the other half “dummy infusions” for 18 months.
If enough amyloid cleared out, patients were switched to dummy infusions. About half of the participants were switched, The Associated Press said.
In the end, both groups declined cognitively during the 18-month study, but the people administered donanemab worsened about 22% more slowly. Those with low to medium levels of tau — another protein that contributes to Alzheimer’s disease — experienced a 35% slower decline.
The report, which was published in the Journal of the American Medical Association, concluded that donanemab slowed the decline of patients’ cognitive abilities by about four to seven months.
“This approval marks another step forward in evolving the standard of care for people living with Alzheimer’s disease that will ultimately include an arsenal of novel treatments, providing much-needed hope to the Alzheimer’s community. As a physician, I am encouraged by the potential to stop treatment, which could reduce out-of-pocket costs and infusion burden for eligible patients,” said Howard Fillit, co-founder and chief science officer at the Alzheimer’s Drug Discovery Foundation (ADDF), in an Eli Lilly news release issued Tuesday. “Diagnosing and treating Alzheimer’s sooner than we do today has the potential to meaningfully slow disease progression, giving patients invaluable time to maintain their independence for longer.”
Donanemab isn’t perfect, though.
Much like Leqembi, one of the medication’s most concerning side effects is brain swelling or bleeding, which usually presents no symptoms but can be deadly.
An estimated 6.9 million Americans 65 years and older are living with Alzheimer’s disease, according to the Alzheimer’s Association.
Damage to nerve cells in areas of the brain responsible for memory, language and thinking are the cause for the disease and can start even 20 years earlier than when a person is diagnosed. Someone is diagnosed with Alzheimer’s dementia when their symptoms have become so severe that they cannot perform everyday tasks, the Alzheimer’s Association explained.
The National Institute of Health said that the number of people living with Alzheimer’s could grow to almost 14 million by 2060 if there is no development of breakthrough medicines to prevent, slow or cure the disease.
Donanemab is one of many treatments and studies that Cummings has been keeping track of for his annual Alzheimer’s disease drug development pipeline reports.
First published in 2016, Cummings and his team release a yearly review of the strides being made in relation to Alzheimer’s disease research — a document that he said had been downloaded thousands of times. There are 164 clinical trials assessing 127 potential drugs for Alzheimer’s disease as of April 24, Cummings’ report shows.
It’s a drop from the 187 clinical trials, 141 drugs and 101 chemical entities that were being researched in 2023, he notes.
Cummings hopes this decrease in studies isn’t a trend, especially since it takes an average of 13 years for potential Alzheimer’s disease therapy to progress from nonclinical studies to FDA review, according to his 2024 review.
The goal is — like with other diseases — eradicating it, and Cummings believes the future will soon bring more drugs or treatments that could be used together to slow the progression of cognitive decline.
It’s especially possible with the increase of biological markers — medical signs or characteristics observed in living organisms — that are helping researchers understand how Alzheimer’s disease changes the brain’s biology.
“(There’s) hope for patients and caregivers; you just think of the families that are surrounding us in the city and they’re invisible in their homes, but they’re waiting for treatment,” Cummings said. “If you look at the field, it has much more positivity, much more momentum than it has ever had in the 40 years that I have been in the field. I think we have turned the corner; that we understand the processes that are driving this disease, and therefore, we have much more of an opportunity.”
