FDA has Granted Accelerated Approval for Leqembi

FDA Has Granted Accelerated Approval For Leqembi

Leqembi (lecanemab-irmb), a medication for treating Alzheimer’s, received approval from the U.S. Food and Drug Administration via the Accelerated Approval pathway on January 6th, 2023. Leqembi is the second drug in a newly approved class for Alzheimer’s that addresses the illness’s basic pathophysiology. These drugs are a significant step forward in the ongoing endeavor to find an effective treatment for the disease.

The Accelerated Approval pathway allows the FDA to approve medications for life-threatening illnesses when there is an unmet medical need and that medicine has shown to have an impact on a surrogate endpoint that is relatively likely to predict a clinical benefit for patients.

According to the press release, Billy Dunn, MD, head of the neuroscience division of the FDA’s Center for Drug Evaluation and Research, stated, “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”

The approval came following a review of Phase III randomized controlled clinical trial data published in The New England Journal of Medicine in November 2022. The findings demonstrated that Leqembi (lecanemab-irmb, Eisai) lowered amyloid markers in early Alzheimer’s and resulted in less cognitive and functional decline. According to the news release, the agency would soon receive the trial’s results to verify the drug’s clinical benefit. Eisai R&D Management Co., Ltd. received approval for Leqembi.

Results of the Clinical Trials for Leqembi

Researchers assessed the efficacy of Leqembi in a double-blind, placebo-controlled, parallel-group, dose-finding study comprising 856 Alzheimer’s patients. Patients with mild cognitive impairment (MCI) or mild dementia stage of the disease and confirmed presence of amyloid beta pathology underwent treatment.

Patients who received the recommended dose of lecanemab, 10 mg/kilogram every two weeks, saw a considerable time- and dose-dependent reduction in the amount of amyloid beta plaque. It demonstrated a statistically significant decrease in brain amyloid plaque from baseline to Week 79 when compared to the placebo arm, which showed no decline in amyloid beta plaque.

These findings support Leqembi’s Accelerated approval, which is justified by the reported decline in amyloid-beta plaque levels, a sign of Alzheimer’s disease. Researchers quantified the amyloid beta plaque via positron emission tomography (PET) imaging to compare the levels of amyloid beta plaque in a composite of brain regions expected to be severely affected by the pathology of Alzheimer’s to a brain region expected to be spared from such pathology.

Prescribing Information for Leqembi

Leqembi comes with a warning for amyloid-related imaging abnormalities (ARIA), which are known to happen with the antibodies from this class. ARIA is typically asymptomatic, though severe and life-threatening events are rare.

Although some patients may experience symptoms like headache, disorientation, dizziness, altered vision, nausea, and seizures, the most common sign of ARIA is transient swelling in brain regions that often goes away with time.

Besides, there is also a possibility of infusion-related responses, which can cause flu-like symptoms, nausea, vomiting, and changes in blood pressure. Leqembi’s most frequent adverse effects included headache, ARIA, and infusion-related problems.

Leqembi is intended for Alzheimer’s treatment, as stated in the prescribing information. According to the labeling, Leqembi treatment should begin in patients with mild cognitive impairment or mild dementia stage of disease, the population in whom treatment was evaluated in clinical trials. Additionally, the labeling states that there are no safety or efficacy data regarding starting the treatment at earlier or later stages of the disease than were investigated.


  1. FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment. FDA News Release. Published online: 6th Jan, 2023. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment. Accessed: 10th Jan, 2023.
  2. van Dyck, C.H., Swanson, C.J., Aisen, P., Bateman, R.J., Chen, C., Gee, M., Kanekiyo, M., Li, D., Reyderman, L., Cohen, S. and Froelich, L., 2022. Lecanemab in early Alzheimer’s disease. New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/NEJMoa2212948
  3. FDA grants accelerated approval for Leqembi. European Pharmaceutical Review. Published online: 9th Jan, 2023. https://www.europeanpharmaceuticalreview.com/news/178331/fda-grants-accelerated-approval-for-leqembi-alzheimers/. Accessed: 10th Jan, 2023.
  4. FDA grants accelerated approval for Alzheimer’s treatment. Healio.com. Published online: 6th Jan, 2023. https://www.healio.com/news/neurology/20230106/fda-grants-accelerated-approval-for-alzheimers-treatment. Accessed: 10th Jan, 2023.
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