FDA Approves Supplemental Biologics License Application for Intravenous Maintenance Dosing of Leqembi in Alzheimer Disease
Approval was based on results from multiple studies, which demonstrated a slowing of cognitive decline in patients with Alzheimer disease administered Leqembi.
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The FDA has approved a Supplemental Biologics License Application (sBLA) for intravenous maintenance dosing of Eisai and Biogen’s Leqembi (lecanemab) once every four weeks for patients with early Alzheimer disease (AD). According to Biogen, approval was based on data from the multiple studies, including the Phase III Clarity AD trial. The approval follows the treatment's prior indicated regimen of biweekly dosing during an 18-month initiation phase, after which clinicians may transition patients to the less frequent maintenance dosing while maintaining clinical and biomarker benefits.1
The global confirmatory placebo-controlled, double-blind, parallel-group, randomized Clarity AD trial consisted of 1,795 people with early-stage AD and included 235 sites across North America, Europe, and Asia. All participants were randomly assigned in a 1:1 ratio to receive either placebo or Leqembi biweekly. The primary endpoint of the study was change from baseline at 18 months in the Clinical Dementia Rating Sum of Boxes. The key secondary endpoint was the change from baseline at 18 months in amyloid Positron Emission Tomography using Centiloids.
Leqembi was found to slow disease progression by 24% at 18 months. Additionally, the treatment decline of activities of daily living was 37% at 18 months. Further, mean change in Centiloids at 18 months was -55.5 for Leqembi and 3.6 for the placebo group.2
Common adverse events included amyloid-related imaging abnormalities (ARIA), ARIA-H, ARIA-E, headache, superficial siderosis of central nervous system, nausea, and vomiting. Infusion-related reactions were observed in 75% of patients during the first dose of Leqembi, and were mostly mild or moderate in severity, including fever and flu-like symptoms, nausea, vomiting, hypotension, hypertension, and oxygen desaturation.1
Earlier this month, the FDA accepted an additional BLA for a subcutaneous (SC) maintenance dosing option of Leqembi based on data from the open-label extension study of Clarity AD.3
According to the Alzheimer’s Association, an estimated 6.9 million people in the United States over 65 years of age are currently living with AD, while 73% are 75 years of age or older. Additionally, two-thirds of people with AD are women. It is projected that by 2050, the number of people over 65 years of age with AD will grow to an estimated 12.7 million, barring the development of medical breakthroughs to prevent or cure AD.
Between 2000 and 2021, deaths from AD have more than doubled, with current numbers indicating that it kills one in every three older people in the United States annually. People over 70 years of age are twice as likely to die before reaching 80 years of age than those without it. For people over 65 years of age, survival of four to eight years is considered the average rate; however, some live as long as 20 years with the disease.4
According to the World Health Organization, over 55 million people are currently living with dementia globally, of whom 60% live in low- and middle-income countries. AD is the most common form of dementia, contributing to anywhere from 60% to 70% of all cases. It is currently the seventh leading cause of death worldwide.5
The FDA assigned the BLA for an SC autoinjector version of Leqembi with a Prescription Drug User Fee target action date of August 2025. The companies expect the new maintenance dosing option to improve treatment accessibility and adherence for patients and caregivers.1
References
1. FDA Approves LEQEMBI® (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease. Biogen. January 26, 2025. Accessed January 27, 2025. https://investors.biogen.com/news-releases/news-release-details/fda-approves-leqembir-lecanemab-irmb-iv-maintenance-dosing
2. Eisai Presents Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer’s Disease At Clinical Trials On Alzheimer’s Disease (Ctad) Conference. Biogen. November 29, 2022. https://investors.biogen.com/news-releases/news-release-details/eisai-presents-full-results-lecanemab-phase-3-confirmatory
3. FDA Accepts Eisai, Biogen’s Biologics License Application for Subcutaneous Leqembi in Early Alzheimer Disease. PharmExec. January 14, 2025. Accessed January 27, 2025. https://www.pharmexec.com/view/fda-accepts-eisai-biogen-biologics-license-application-subcutaneous-leqembi-early-alzheimer-disease
4. Alzheimer's Disease Facts and Figures. Alzheimer’s Association. Accessed January 27, 2025. https://www.alz.org/alzheimers-dementia/facts-figures#:~:text=navigate%20dementia%20care.-,Prevalence,other%20dementias%20as%20older%20Whites.
5. Dementia. WHO. Accessed January 27, 2025. https://www.who.int/news-room/fact-sheets/detail/dementia
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