FDA Approves Lecanemab-Irmb Maintenance Dosing for Early Alzheimer Disease Treatment

Author(s):

Luke Halpern, Assistant Editor

Key Takeaways

The FDA approved lecanemab-irmb for maintenance dosing every four weeks for early Alzheimer's disease patients.
Approval is based on data from phase 2 and Clarity AD studies, showing sustained clinical benefits.
Transitioning to four-week dosing after 18 months of biweekly administration maintains treatment efficacy.

Administered every 4 weeks, the approval could serve as a breakthrough for easier and more effective care for patients with early Alzheimer disease.

The FDA approved the supplemental biologics license application for maintenance dosing of lecanemab-irmb (Leqembi; Eisai, Biogen) administered intravenously once every 4 weeks for the treatment of patients with early Alzheimer disease (AD) who exhibit mild cognitive impairment or mild dementia stage of disease, according to a news release from Eisai and Biogen.¹

Alzheimer s Awareness Concept Human Brain with Missing Puzzle Pieces

Image Credit: © BOJOShop | stock.adobe.com

Approval of the biologic is based on modeling observed data from a phase 2 proof-of-concept study of lencanemab-irmb in patients with early AD (Study 201; NCT01767311) and the Clarity AD study (Study 301; NCT03887455). Simulations have indicated that transitioning patients to maintenance dosing every 4 weeks following 18 months of biweekly administration can maintain the clinical benefits of treatment.^2,3,4,5

Furthermore, an open-label extension of the Clarity AD trial found that patients treated with lecanemab-irmb continued to show treatment benefits through 36 months. According to the news release, lecanemab-irmb clears protofibrils and plaque that are associated with the progression of AD. Data indicates that patient who discontinue treatment face a re-accumulation of amyloid biomarkers and clinical decline, indicating sustained maintenance dosing a critical need for patients with early AD.⁶

About the Trial

Trial Name: A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (Clarity AD)

ClinicalTrials.gov ID: NCT03887455

Sponsor: Eisai Inc.

Estimated Study Completion: September 15, 2027

Experts believe that protofibrils contribute to AD-associated brain injury, causing injury to neurons which can negatively impact cognitive function and play a primary role in cognitive decline. Lecanemab works to reduce damage to neurons in the brain and reduce the presence of protofibrils, which could prevent the progression of AD.¹

“For maintenance treatment, once every 4 weeks dosing regimen may be easier than once every 2 weeks dosing for patients and care partners to continue treatment for early AD,” the news release read. “Ongoing treatment can slow disease progression and prolong the benefit of therapy, with the goal of helping patients maintain who they are for longer.”¹

Patients in the core Clarity AD trial who were treated with lecanemab showed a -0.45 (P < .0001) mean change from baseline on the Clinical Dementia Rating – Sum of Boxes (CDR-SB) global cognitive and functional scale compared with the placebo group. In addition, across 3 years in both the core Clarity AD study and its long-term extension, lecanemab reduced cognitive decline on the CDR-SB by -0.95, indicating a clinically significant treatment benefit for patients with early AD.^1,4

Maintenance dosing with lecanemab-irmb could allow for more optimal treatment and condition management for pharmacists and treatment providers. Pharmacists, who often check in with their parents during common interactions, can assess those who are on treatment with lecanemab to see if they would benefit from maintenance dosing. The less-frequent dosing regimen associated with maintenance lecanemab-irmb as indicated by the FDA could make it easier for pharmacists to administer to patients and make it more likely that patients will continue their treatment beyond 18 months.⁷

REFERENCES

1. Eisai US. FDA approves Leqembi (lecanemab-irmb) IV maintenance dosing for the treatment of early Alzheimer’s disease. News Release. Released January 26, 2025. Accessed January 27, 2025. https://media-us.eisai.com/2025-01-26-FDA-Approves-LEQEMBI-R-lecanemab-irmb-IV-Maintenance-Dosing-for-the-Treatment-of-Early-Alzheimers-Disease

2. McDade E, Cummings JL, Dhadda S, et al. Lecanemab in patients with early Alzheimer’s disease: detailed results on biomarker, cognitive, and clinical effects from the randomized and open-label extension of the phase 2 proof-of-concept study. 2022;14(191). doi:10.1186/s13195-022-01124-2

3. ClinicalTrials.gov. A study to evaluate safety, tolerability, and efficacy of lecanemab in subjects with early Alzheimer’s disease. National Library of Medicine. Last Updated January 22, 2025. Accessed January 27, 2025. https://clinicaltrials.gov/study/NCT01767311

4. Van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in early Alzheimer’s disease. N Engl J Med. 2023;388(1):9-21. doi:10.1056/NEJMoa2212948

5. ClinicalTrials.gov. A study to confirm safety and efficacy of lecanemab in participants with early Alzheimer’s disease (Clarity AD). National Library of Medicine. Last Updated July 9, 2024. Accessed January 27, 2025. https://clinicaltrials.gov/study/NCT03887455

6. McGovern G. Open-label trial extension supports continued long-term treatment with lecanemab in patients with early AD. Pharmacy Times. Published August 2, 2024. Accessed January 27, 2025. https://www.pharmacytimes.com/view/open-label-trial-extension-supports-continued-long-term-treatment-with-lecanemab-in-patients-with-early-ad

7. McGovern G. Pharmacists can help patients navigate current treatment landscape of Alzheimer disease. Pharmacy Times. Published January 10, 2025. Accessed January 27, 2025. https://www.pharmacytimes.com/view/pharmacists-can-help-patients-navigate-current-treatment-landscape-of-alzheimer-disease