The FDA recently approved donanemab, a treatment for Alzheimer’s disease that is designed to slow the progression of the early signs of dementia.
Donanemab, made by Eli Lilly, based in Indianapolis, is a monoclonal antibody treatment that assists the body in removing the hallmark plaque that builds up in the brain and leads to dementia.
Clinical trials have demonstrated the treatment slowed down cognitive decline in patients by up to 35 percent.
Now that it is approved, Eli Lilly said it will be marketed under the name Kisunla and administered monthly by IV infusions. It will cost $695 per vial, up to around $32,000 annually. While a breakthrough in Alzheimer’s care, experts have raised worries about donanemab because of known risks of brain bleeds, which killed numerous trial patients.
Dr. Howard Fillit, co-founder and chief science officer at the Alzheimer’s Drug Discovery Foundation (ADDF), said in a press release: “This approval marks another step forward in evolving the standard of care for people living with Alzheimer’s disease, which will eventually include a plethora of unique treatments, providing the necessary hope to the Alzheimer’s community.
“Diagnosing and treating Alzheimer’s sooner than we do today has the potential to slow disease progression meaningfully, giving patients invaluable time to maintain their independence for longer.”
According to Eli Lilly, the drug slowed functional and cognitive decline in patients by as much as 35 percent compared to placebo over 18 months.
It also lowered patients’ risk of moving into advanced stages of Alzheimer’s by as much as 39 percent.
Additionally, the trial also found that donanemab reduced amyloid plaques in the brains of participants by an average of 61 percent at six months, 80 percent at 12 months, and 18 percent at 18 months compared to placebo.
While donanemab has been touted as a possible therapy, one-quarter of patients in the Eli Lilly trial suffered brain swelling, with three people dying from bleeding or brain swelling attributed to the drug.
In addition, patients who received donanemab had a slightly increased mortality rate — two percent, when compared with 1.7 percent who were given a placebo.
While the aging population of the United States continues to grow, so will dementia rates. An estimated 6.7 million Americans have Alzheimer’s disease currently — the most common cause of dementia — the majority of whom are over age 65.
By 2050, this number is predicted to rise to almost 13 million.
Although the leading cause of Alzheimer’s disease is continuing to be debated, scientists believe the damage is likely to be the result of abnormal protein build-up — tau and amyloid — in and around brain cells.
In patients with Alzheimer’s, amyloid proteins aren’t effectively cleared from the body and eventually form brain plaques. Tau proteins form tangles after detaching from neurons.
Both of these can lead to neuron death, making it challenging to deliver signals throughout the brain.
Donanemab was designed to target amyloids. When infused into the body through an IV, the monoclonal antibodies travel to the brain.
Once donanemab is inside the organ, it binds to toxic build-ups of amyloid plaque, prompting immune cells — also known as microglia — to clear them.
Once the amyloid accumulation has been cleared from the brain, patients stop taking donanemab.
The treatment is meant for people with mild cognitive impairment or early symptomatic Alzheimer’s disease.
Donanemab isn’t the first monoclonal antibody to be approved by the FDA. Lecanemab, sold as Leqembi, is already being utilized to treat Alzheimer’s patients.
Despite its risks, families and patients in the donanemab trial said the new drug for dementia finally gives sufferers a sliver of ‘hope.’
