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The companies are seeking accelerated approval based on the surrogate end point of beta amyloid reduction.
Biogen and Eisai have initiated a rolling submission to the FDA of a biologics license application (BLA) for lecanemab, an anti-amyloid beta protofibril antibody, for the treatment of early Alzheimer’s disease. The application is being submitted under the accelerated approval pathway based on a trial that uses beta amyloid reduction as a surrogate end point.
A phase 2b clinical trial in people with early Alzheimer’s disease and confirmed amyloid pathology showed lecanemab lowered beta amyloid plaque and reduced clinical decline across several clinical endpoints.
The results of this study were published in April 2021. This study was designed as an 18-month, proof-of-concept study. The study explored the dose response of lecanemab over three dose levels and two dosing regimens with the objective to establish the most effective (ED90) dose of lecanemab.
Investigators found, however, that lecanemab did not meet the primary end point, which was a 12-month clinical change on the Alzheimer’s Disease Composite Score. Investigators did find that on the 18-month Bayesian and other analyses, lecanemab demonstrated reduction in brain amyloid accompanied by a consistent reduction of clinical decline across several clinical and biomarker end points based on the Alzheimer’s Disease Composite Score.
A phase 3 confirmatory study continues. This study completed enrollment in March 2021.
In June 2021, lecanemab was granted breakthrough therapy designation. Eisai has an agreement with the FDA to submit the BLA for lecanemab as a rolling submission. This agreement allows completed portions of the application to be submitted to the FDA for review on an ongoing basis. After all portions are submitted to the FDA and the agency accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date will be set.