ALL ABOUT THE LATEST ANTI-AMYLOID ALZHEIMER’S DRUG
On July 2, the FDA approved a new Alzheimer’s drug called donanemab, which will be marketed under the brand name Kisunla. Developed by Eli Lilly, this drug is an antibody designed to remove beta-amyloid plaques that accumulate in the brains of Alzheimer’s patients. It is similar to another drug, lecanemab (brand name Leqembi), made by Eisai and Biogen. (Refer to my August 2023 post Lecanemab: the new Alzheimer’s Drug.) This marks the third amyloid-clearing Alzheimer’s drug approved in the last three years. In 2021, the FDA approved Biogen’s aducanumab (sold as Aduhelm), despite mixed clinical study results, and it has recently been discontinued. (Refer to my June 2021 post The New Alzheimer’s Drug – Who Knows if it Even Works?)
Kisunla and Leqembi are considered only an incremental step in the search for effective Alzheimer’s treatments. Some researchers say they may not slow decline enough to be noticeable to patients or families. Many Alzheimer’s experts are skeptical of the anti-amyloid drugs and said they believed the risks outweighed the potential for only a slight benefit.
Nevertheless, clinical studies have shown that in many persons with a mild form of Alzheimer’s, these more recent drugs can slow the unfolding of dementia by several months. I did a bit of research and came across this online July 2, 2024 USA Today online article by Ken Alltucker, titled FDA approves a new Alzheimer’s drug. What to know about Eli Lilly’s Kisunla. Here are excerpts:
Kisunla
The Food and Drug Administration on Tuesday approved the experimental Alzheimer’s drug donanemab, which slowed the early stages of the fatal mind-robbing disease in studies.
Eli Lilly said Kisunla will be marketed as a monthly injection, which will be administered via IV infusion. The Alzheimer’s treatment will be available for adults with early symptoms of Alzheimer’s disease, which includes mild cognitive impairment and mild dementia. Patients will be tested for amyloid before starting the medication.
Kisunla is the only amyloid-targeting drug for which studies provide evidence treatments can be discontinued when amyloid plaques are removed, Eli Lily added. The company said that can result in lower costs and fewer infusions. The company expects to make the drug available in two weeks, officials said.
Eli Lilly said the price will depend on how quickly the drug clears amyloid plaques from patients. Studies showed 17% of patients completed treatment at six months while 69% took the drug for 18 months. Based on that scenario, Lilly said the drug cost would range from $12,522 for six months to $48,696 for 18 months.
Clinical studies showed people with a mild form of the disease reduced cognitive decline by 35% compared with those who took a placebo. Cognitive decline was assessed by a test that measures memory, thinking, and daily functioning.
As it did with Leqembi, the FDA will require Kisunla to include a warning for MRI-visible injuries called amyloid-related imaging abnormalities, or ARIA, which can include brain swelling and tiny bleeds at the surface of the brain. Most people with ARIA-related side effects don’t experience symptoms, but serious and life-threatening events do occur, the FDA said.
During the advisory panel hearing last month, Lilly officials said three people died from ARIA-related injuries during the study, and another two who continued taking the drug after the study was completed also died from ARIA injuries.
Patients who carry two copies of the Alzheimer’s risk gene, ApoE4, are more likely to get ARIA-related side effects. The FDA said people should take a genetic test to learn whether they carry this genetic risk before starting the treatment.
Joanne Pike, president and CEO of the Alzheimer’s Association, said the new treatment options represent “real progress.”
“Today’s approval allows people more options and greater opportunity to have more time,” Pike said in a statement. “Having multiple treatment options is the kind of advancement we’ve all been waiting for – all of us who have been touched, even blindsided, by this difficult and devastating disease.”