Leqembi FDA Approval History
Last updated by Judith Stewart, BPharm on July 10, 2023.
FDA Approved: Yes (First approved January 6, 2023)
Brand name: Leqembi
Generic name: lecanemab-irmb
Dosage form: Injection
Company: Biogen Inc. and Eisai Co., Ltd.
Treatment for: Alzheimer's Disease
Leqembi (lecanemab) is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease.
- Alzheimer’s disease (AD) is a progressive neurological disease that slowly destroys the memory and thinking skills. The disease is widely believed to be driven by the production and deposition of the amyloid-beta peptide.
- Leqembi contains lecanemab, which is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid-beta. Lecanemab is thought to slow down the progression of Alzheimer’s disease by neutralizing and eliminating soluble, toxic amyloid-beta aggregates (protofibrils) that may contribute to the neurodegenerative process.
- The U.S. Food and Drug Administration (FDA) granted Leqembi accelerated approval on January 6, 2023, and traditional approval on July 6, 2023. Leqembi’s traditional approval is based on Phase 3 data from Eisai’s large, global Clarity AD clinical trial, in which Leqembi met its primary endpoint and all key secondary endpoints with statistically significant results and confirmed the clinical benefit of Leqembi.
- Treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. The presence of amyloid-beta pathology should be confirmed prior to initiating treatment.
- Leqembi is administered as an intravenous infusion over approximately one hour, once every two weeks.
- The Leqembi product label carries a Boxed Warning for the risk of Amyloid Related Imaging Abnormalities (ARIA). ARIA is usually asymptomatic, although rarely serious and life-threatening events can occur. Serious intracerebral hemorrhage greater than 1 cm have occurred in patients treated with this class of medications. The use of anticoagulant or thrombolytic medications while taking Leqembi may increase the risk of bleeding in the brain. Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment with Leqembi.
- Warnings and precautions associated with Leqembi include ARIA, hypersensitivity reactions, and the potential risk of infusion-related reactions, which can include flu-like symptoms, nausea, vomiting, and changes in blood pressure, the majority of which occur with the first infusion.
- Common adverse reactions include infusion-related reactions, amyloid related imaging abnormality-microhemorrhages, amyloid related imaging abnormalityedema/effusion, and headache.
Development timeline for Leqembi
Further information
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