HQ Team
July 9, 2025: The US drug regulator has approved changes in the prescription of Eli Lilly’s drug Kisunla for treating adults with early Alzheimer’s disease, including those with mild memory problems or mild dementia.
The US Food and Drug Administration gave its nod for a new way of starting the treatment, called a titration dosing schedule, which means the medicine is introduced more gradually, according to a company statement.
The USFDA move comes after donanemab, branded as Kisunla, was placed under its boxed safety warning on the prescribing label, warning of the risk of potentially life-threatening brain swelling and bleeding.
Eli Lilly has updated the instructions. A new, slower start to the treatment helps reduce a common side effect called ARIA-E, which is swelling or fluid buildup in the brain seen on scans.
Amyloid plaques
ARIA-E usually doesn’t cause symptoms and can sometimes be serious. The updated schedule lowered the chance of this side effect by about 40% in the first six months and by 35% after a year, compared to the original way of giving the drug.
The slower dosing does not reduce how well Kisunla works. It still removes the harmful amyloid plaques in the brain (which are linked to Alzheimer’s) and lowers another protein called P-tau217, which is also involved in the disease.
The new dosing plan shifts some of the medicine from the first dose to later doses but keeps the total amount the same for six months.
It starts with a single vial, adding a vial each month until reaching the full four-vial dose at month four. The previous schedule was for two vials monthly until moving to the full dose at month four.
Brain swelling
Patients still get the medicine once a month, and this approach might allow some people to stop treatment once their amyloid plaques are reduced to very low levels.
In the study supporting this prescription change, fewer patients had brain swelling or related issues with the new schedule, and the drug’s benefits remained strong.
No new side effects were found, though some patients had allergic or infusion-related reactions, which are known risks.
Interim data from the study were revealed last year. A gradual dosing schedule reduced the percentage of patients experiencing potentially serious brain swelling.
‘Mitigating risk’
At week 24 of the year-long study, 14% of patients with early-stage Alzheimer’s who received a lower starting dose of the monthly infusion had ARIA-E. That compared with 24% of those who received the standard dosing schedule.
“We are confident that this label update for Kisunla will significantly aid healthcare professionals in evaluating appropriate treatment options for their patients,” said Brandy Matthews, MD, FAAN, Lilly’s Vice President of Global & US Medical Affairs for Alzheimer’s Disease.
“This update underscores our unwavering commitment to patient safety and the advancement of Alzheimer’s disease treatment by potentially mitigating the risk of ARIA-E,” she said.
The USFDA approved Kisunla in July 2024 based on the end-stage clinical trial data.
Alzheimer’s is the most common form of dementia, and it is a progressive neurodegenerative disease that affects memory, thinking, and behaviour.
