FDA Grants Priority Review for Lecanemab for Alzheimer’s Disease


Lecanemab is monoclonal antibody that targets beta amyloid to treat mild cognitive impairment. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of Jan. 6, 2023.

The FDA has accepted the biologics license application (BLA) under the accelerated approval pathway for lecanemab to treat patients with Alzheimer’s disease. Eisai's application, which was completed in early May 2022, has been granted priority peview, with a Prescription Drug User Fee Act (PDUFA) action date of Jan. 6, 2023.

Lecanemab is an investigational anti-amyloid beta antibody being developed jointly by Eisai and Biogen for the treatment of mild cognitive impairment due to Alzheimer’s disease. It is the second Alzheimer's therapy to come from the collaboration behind Aduhelm.

Related: Eisai Completes Submission of Lecanemab for Alzheimer’s Disease

The submission is based on clinical, biomarker and safety data from the proof-of-concept phase 2b in 856 people with early Alzheimer’s disease with confirmed presence of amyloid pathology, biomarker and safety data from an open-label extension study, and blinded safety data from the confirmatory phase 3 study.

The phase 2b study explored the impact of treatment with lecanemab on reducing amyloid plaque and clinical decline. At 18 months of treatment, lecanemab reduced brain amyloid by a mean of 0.306 standardized uptake value ratio (SUVR)—a common quantitative method used to measure comparisons using positron emission tomography (PET). More than 80% of patients became amyloid negative by visual read.

The Clarity AD phase 3 clinical study for lecanemab in early Alzheimer’s disease is ongoing, and Eisai completed enrollment in March 2021 with 1,795 patients. Primary endpoint data will be available in the fall of 2022. The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab.

In June 2022, Eisai released the second of two economic analyses of lecanemab. The most recent analysis, published in the journal Neurology and Therapy, addressed the healthcare payer perspective, which focused on direct care costs (e.g., outpatient and inpatient services, medications, intervention costs, nursing home and home healthcare services).

This analysis used the simulation model AD Archimedes Condition Event (AD ACE), and found that lecanemab would potentially improve long-term health outcomes and reduce formal and informal care costs. Lecanemab plus standard of care was predicted to result in a gain of 0.61 quality-adjusted life years and a $8,707 decrease in total non-treatment costs vs. standard of care alone for patients with early Alzheimer’s disease.

The first analysis, also published in journal Neurology and Therapy in April 2022, focused on the societal perspective addressing productivity loss and informal care costs. This analysis found that treatment with lecanemab would translate to a lower lifetime probability of transitioning to Alzheimer’s dementia or institutional care, and increased mean survival in the community compared with standard of care (25% for lecanemab plus standard of care versus 31% for standard of care alone).

In Europe, based on the results of the Clarity AD study, Eisai plans to submit a new drug application in fiscal year 2022.

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