Eisai initiates rolling submission to FDA for early Alzheimer’s treatment

Eisai has initiated a rolling submission to the US FDA of a Biologics License Application (BLA) for lecanemab (BAN2401), the company’s investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer’s disease (early AD).

The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial (Study 201) in people with early AD and confirmed amyloid pathology.

The lecanemab Phase 2b trial results demonstrated a high degree of Aβ plaque lowering and consistent reduction of clinical decline across several clinical endpoints.

The correlation between the extent of Aβ plaque reduction and effect on clinical endpoints in Study 201 further supports Aβ as a surrogate endpoint that is reasonably likely to predict clinical benefit.

Eisai is utilizing the accelerated approval pathway after discussion with the FDA and aims to bring a new treatment option to people living with early AD, their families and healthcare professionals.

In June, lecanemab was granted Breakthrough Therapy designation. Now, 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 (target date for completion of examination) will be set.

The BLA submission is primarily based on the results of the proof-of-concept Study 201 in 856 patients with mild cognitive impairment (MCI) due to AD and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology.

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