FDA Grants Traditional Approval to Leqembi for the Treatment of Alzheimer Disease

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Announcement follows the FDA’s accelerated approval and unanimous endorsement of the drug earlier this year.

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The US Food and Drug Administration (FDA) has granted traditional approval to Leqembi (lecanemab) for the treatment of Alzheimer disease.

The FDA’s decision to grant traditional approval was based on the results of a confirmatory trial, which verified the clinical benefits of the drug.1 Leqembi was granted accelerated approval by the FDA in January 20232 and unanimously endorsed for its clinical benefit and efficacy by an FDA Advisory Committee in June 2023.3 It is now the first amyloid beta-directed antibody for the treatment of Alzheimer disease to be switched from accelerated to traditional approval.1

“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” said Teresa Buracchio, acting director of the FDA Center for Drug Evaluation and Research Office of Neuroscience, in a press release. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”

Psychiatric Times® asked several psychiatric experts for their thoughts on what the approval of Leqembi means for psychiatry and for the care of patients with Alzheimer disease. Here is what they told us.

“The unanimous endorsement of the FDA advisory committee as part of the traditional approval process is a validation of the efficacy and clinical benefits of lecanemab in the treatment of Alzheimer’s disease. This represents a giant step forward in finding effective treatments for this devastating illness.”
Rajesh R. Tampi, MD, MS, DFAPA, DFAAGP
  • Professor and chairman of the Department of Psychiatry at Creighton University School of Medicine and Catholic Health Initiatives Health Behavioral Health Services
  • Adjunct professor of psychiatry at Yale School of Medicine

“The FDA approval of lecanemab is an important milestone for millions of those suffering from mild to moderate Alzheimer’s disease and their families that will allow the disease-modifying drug to delay the progression of Alzheimer’s disease by 6 months or longer. It comes with the controversies of high cost of the drugs, modest efficacy, complex and expensive monitoring of CNS severe side effects (ARIA), but it also opens the age of the disease-modifying treatments that were not previously available, and the realization for the need of multi-component interventions that include lifestyle, cognitive training, and other preventive strategies.”
Helen Lavretsky, MD, MS
  • Professor in residence in the UCLA Department of Psychiatry
  • President-elect of the American Association for Geriatric Psychiatry
  • Distinguished fellow of the American Psychiatric Association and of the American Association for Geriatric Psychiatry
  • Fellow of the American College of Neuropsychopharmacology
  • Psychiatric Times board member

“The ‘traditional approval’ of lecanemab (Leqembi™, Eisai) by the FDA is a big win for patients with mild cognitive impairment or early dementia due to Alzheimer’s disease, as Medicare has stated it would likely pay for this drug for appropriate patients with this full approval. The next challenge will be to establish infusion clinics for Leqembi, which requires IV administration every 2 weeks. The real test will be monitoring Leqembi's impact on slowing the progression of Alzheimer’s disease in patients receiving it, and the degree of disease modification.”
John J. Miller, MD
  • Medical director at Brain Health
  • Editor in chief of Psychiatric Times
  • Staff psychiatrist at Seacoast Mental Health Center
  • Consulting psychiatrist at Exeter Hospital and Insight Meditation Society

References

1. FDA converts novel Alzheimer’s disease treatment to traditional approval. US Food and Drug Administration. News release. July 6, 2023. Accessed July 6, 2023. https://www.fda.gov/news-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval

2. FDA approves LEQEMBI™ (lecanemab-irmb) under the Accelerated Approval Pathway for the treatment of Alzheimer’s disease. Biogen. News release. January 6, 2023. Accessed July 5, 2023. https://investors.biogen.com/news-releases/news-release-details/fda-approves-leqembitm-lecanemab-irmb-under-accelerated-approval

3. FDA Advisory Committee unanimously confirms efficacy and clinical benefit of Leqembi for early Alzheimer’s disease. Alzheimer’s Impact Movement. June 9, 2023. Accessed July 5, 2023. https://alzimpact.org/FDA/Advisory-Committee-Unanimously-Confirms-Efficacy-and-Clinical-Benefit-of-Leqembi#:~:text=The%20FDA%20has%20granted%20Priority,early%20stages%20of%20the%20disease

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