To reduce the risk of brain oedema (ARIA-E), the updated protocol now allows for treatment to begin with one vial per month, increasing by one vial each month up to four vials by the fourth month. Previously, patients would begin with two vials monthly.
Currently, more than 6 million people in the United States are living with Alzheimer’s disease, highlighting the urgent need for safe and effective treatments.
Kisunla was approved last year after clinical trials showed a 29% slower decline in memory and thinking compared to placebo.
However, due to the potential for serious side effects — including brain swelling and haemorrhages — the drug carries the FDA’s highest level of warning: a black box label.
According to Eli Lilly, 24% of patients on the standard dose experienced ARIA-E brain swelling, while only 14% did with the gradual dose escalation — with no reduction in treatment efficacy.
Dr Brandy Matthews of Eli Lilly noted that the update would help physicians make more informed decisions when discussing treatment options with patients.
Kisunla competes with Leqembi, developed by Biogen and Eisai, which also targets beta-amyloid but carries a similar risk profile. Use of such drugs remains limited due to the need for additional diagnostics and regular MRI scans to monitor for side effects.
The scale of the disease in the US — with over 6 million affected — underscores the importance of developing treatments that are both effective and safe.