FDA Grants Breakthrough Therapy Designation for Alzheimer’s Treatment

The FDA granted Breakthrough Therapy designation for lecanemab in June of 2021. Breakthrough Therapy designation and Fast Track designation are two FDA programs that are intended to facilitate and expedite development of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition such as AD and provide opportunities for frequent interactions with the FDA..    

In September 2021, Eisai initiated a rolling submission to the FDA of a Biologics License application (BLA) for lecanemab under the accelerated approval pathway. The BLA is primarily based on clinical, biomarker and safety data from the Phase 2b clinical study (Study 201) in people with early AD and confirmed amyloid pathology, and non-clinical and clinical parts of the application which consists of three parts (non-clinical, clinical and CMC) have already been submitted. The lecanemab Phase 2b study 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.

The lecanemab Clarity AD Phase 3 clinical study in early AD is ongoing and completed enrollment in March 2021 with 1,795 patients. 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. Blinded safety data from Clarity AD is included to support the ongoing rolling submission. Another Phase 3 clinical study, AHEAD 3-45, is evaluating the efficacy of treatment with lecanemab in participants with preclinical AD and elevated amyloid and in participants with early preclinical AD and intermediate amyloid. Additionally, Eisai has initiated a lecanemab subcutaneous dosing Phase 1 study.

Alzheimer’s Disease is a serious, progressive and devastating disease with few treatment options. Eisai and Biogen are committed to bring new treatment options to people living with early AD, their families and healthcare professionals who are waiting for them as early as possible.