- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- Fact Check
- Bone Health Fact Check
- Brain Health Fact Check
- Cancer Related Fact Check
- Child Care Fact Check
- Dental and oral health fact check
- Diabetes and metabolic health fact check
- Diet and Nutrition Fact Check
- Eye and ENT Care Fact Check
- Fitness fact check
- Gut health fact check
- Heart health fact check
- Kidney health fact check
- Medical education fact check
- Men's health fact check
- Respiratory fact check
- Skin and hair care fact check
- Vaccine and Immunization fact check
- Women's health fact check
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
Eli Lilly gets USFDA okay for updated Kisunla label with new dosing in early symptomatic Alzheimer's disease

Indianapolis:
In the TRAILBLAZER-ALZ 6 study, the modified titration schedule significantly lowered the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) versus the original dosing schedule at 24 and 52 weeks, while still achieving similar levels of amyloid plaque removal and P-tau217 reduction.
"We are confident that this label update for Kisunla will significantly aid healthcare professionals in evaluating appropriate treatment options for their patients," stated
The new recommended dosing regimen involves a more gradual titration, and the TRAILBLAZER-ALZ 6 study significantly lowered the incidence of ARIA-E by 41% at 24 weeks and by 35% at 52 weeks versus the original dosing schedule. ARIA-E is a side effect of amyloid plaque-targeting therapies, including Kisunla. ARIA-E is usually asymptomatic, although serious and fatal events can occur. The new dosing recommendation differs from the original dosing by shifting a single vial from the first dose to the third dose, delivering the same amount of Kisunla by week 24. This resulted in lower rates of ARIA-E without compromising Kisunla's ability to reduce amyloid plaque or Kisunla's once-monthly dosing with the potential for limited-duration treatment based on amyloid plaque removal to minimal levels.3
Key findings from the TRAILBLAZER-ALZ 6 study, which supports this label update, included:
- The primary endpoint of the study was the proportion of participants with any occurrence of ARIA-E by week 24. The results showed the incidence of ARIA-E was 14% in patients receiving the modified titration compared with 24% for those receiving the original dosing regimen, a 41% lower relative risk.7 At week 52, the incidence of ARIA-E was 16% in patients receiving the modified titration compared with 25% for those receiving the original dosing regimen, a 35% lower relative risk.
- Including asymptomatic radiographic events at week 52, ARIA, ARIA-E, and ARIA-H were observed in 29%, 16%, and 25% of patients receiving the modified titration dosing. ARIA-E and ARIA-H are different types of amyloid-related imaging abnormalities (ARIA). ARIA with edema is characterized as ARIA-E and ARIA with hemosiderin deposition is characterized as ARIA-H.
- Patients on the modified titration experienced a reduction of amyloid plaque and P-tau217 comparable to patients receiving the original dosing regimen. As observed using amyloid PET at the primary endpoint of 24 weeks, amyloid plaque levels in patients on the modified titration of donanemab in TRAILBLAZER-ALZ 6 were reduced on average 67% from baseline compared to 69% for patients on the original dosing regimen.7,8
- No new adverse reactions were identified in this study, although higher rates of hypersensitivity reactions and infusion-related reactions were observed.
"This updated dosing strategy is a meaningful advancement for patients and their care teams," said Elly Lee, MD, Chief Medical Officer and Principal Investigator,
Irvine Center for Clinical Research . "By significantly reducing the risk of ARIA-E, we can offer patients and care teams greater confidence in the safety of Kisunla while preserving its ability to reduce amyloid."The
U.S. FDA approved Kisunla inJuly 2024 based on the TRAILBLAZER-ALZ 2 Phase 3 clinical trial data. The study demonstrated that Kisunla significantly slowed cognitive and functional decline in patients who were less pathologically advanced in their disease by up to 35% and by 22% in the overall study population compared to placebo at 18 months.9 Kisunla reduced the risk of progressing to the next clinical stage of disease by 37% over the same period. Cognitive and functional decline was characterized by more severe memory and thinking problems, more trouble with daily activities, and a greater need for help from caregivers.
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751