FDA Panel Unanimously Approves Alzheimer’s Treatment Leqembi

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Decision based on data collected from patients in the early stages of the disease.

Eisai, a pharmaceutical company, and Biogen, a biotechnology organization, have announced the FDA’s approval of Leqembi (lecanemab-irmb), for the treatment of Alzheimer’s disease. The injection is recommended for patients with mild cognitive impairment or mild dementia, the demographic in which clinical trials were introduced.


Reportedly, continued approval is contingent on verification of clinical benefit in a confirmatory trial.

Reference: FDA Advisory Committee Votes Unanimously to Confirm the Clinical Benefit of LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease. June 9, 2023. Accessed June 13, 2023. https://www.globenewswire.com/news-release/2023/06/09/2685832/0/en/FDA-Advisory-Committee-Votes-Unanimously-to-Confirm-the-Clinical-Benefit-of-LEQEMBI-lecanemab-irmb-for-the-Treatment-of-Alzheimer-s-Disease.html