The U.S. FDA converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit. Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease. The drug works by reducing amyloid plaques that form in the brain, a defining pathophysiological feature of the disease. 

The new monoclonal antibody was approved in January under the Accelerated Approval pathway. This pathway allows the FDA to approve drugs for serious conditions where there is an unmet medical need, based on clinical data demonstrating the drug’s effect on a surrogate endpoint—in this, reducing amyloid plaques in the brain—that is reasonably likely to predict a clinical benefit to patients. As a post-marketing requirement of the accelerated approval, the FDA required the applicant to conduct a confirmatory study, to verify the anticipated clinical benefit of the new drug . Efficacy of Leqembi was evaluated using the results of Study 301 (CLARITY AD), a Phase 3 randomized, controlled clinical trial.1

Read more here.

References

  1. Office of the Commissioner. (2023). FDA Converts Novel Alzheimer’s Disease Treatment to Traditional Approval. U.S. Food And Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval

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