The Food and Drug Administration has approved a groundbreaking new Alzheimer’s medication called donanemab, which has shown promise in slowing the early stages of this devastating disease.
This approval follows a recent endorsement from an FDA advisory committee, despite concerns about potential side effects. Donanemab, marketed under the brand name Kisunla, is an antibody that helps remove beta-amyloid plaques found in the brains of Alzheimer’s patients.
Kisunla will be available as a monthly injection administered via IV infusion. It is primarily intended for adults showing early symptoms of Alzheimer’s, such as mild cognitive impairment and mild dementia. A test for amyloid will be conducted before starting the medication.
One significant advantage of Kisunla is that patients may be able to stop treatment once amyloid plaques are sufficiently cleared, potentially reducing both costs and the number of infusions needed. According to Eli Lilly, the drug could be available within two weeks.
The pricing of Kisunla is dependent on how quickly amyloid plaques are cleared from the patient’s brain. Clinical studies revealed that 17% of patients could complete the treatment within six months, while 69% needed treatment for 18 months. Estimated costs range from $12,522 for six months to $48,696 for 18 months.
In clinical studies, Kisunla demonstrated a 35% reduction in cognitive decline for patients with mild Alzheimer’s symptoms compared to those who took a placebo. Cognitive function was measured through tests evaluating memory, thinking, and daily activities.
Kisunla is the third amyloid-clearing Alzheimer’s drug approved since 2021. Previous approvals include Eisai and Biogen’s Leqembi, which carries a warning for potential side effects such as brain swelling and tiny bleeds, and Biogen’s aducanumab, which faced mixed results in clinical trials and was subsequently withdrawn from the market.
Similar to Leqembi, Kisunla will also include a warning for MRI-visible complications known as amyloid-related imaging abnormalities (ARIA). These abnormalities may include brain swelling and tiny surface bleeds. While most ARIA-related cases are asymptomatic, serious and life-threatening incidents can occur.
During recent studies, three participants died from ARIA-related complications, and two additional fatalities occurred in patients who continued treatment after the study. Those carrying two copies of the Alzheimer’s risk gene ApoE4 are more prone to ARIA side effects. The FDA recommends genetic testing for this gene before starting Kisunla treatment.
Joanne Pike, president and CEO of the Alzheimer’s Association, regards the approval of Kisunla as a significant milestone in the fight against Alzheimer’s.
“Today’s approval allows people more options and greater opportunity to have more time,” Pike said. “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.”
