On 23 June, Eisai and Biogen have announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (also known as BAN2401), an investigational antibody targeting amyloid beta, for the treatment of Alzheimer's disease (AD). According to the FDA, the Breakthrough Therapy designation is a process designed to expedite the development of drugs that are intended to treat a serious condition. The benefits of a Breakthrough Therapy designation include more intensive guidance on an efficient development program as well as eligibility for rolling review and potentially priority review.
The FDA's decision on lecanemab is based on the recently published results of the Phase IIb clinical trial named Study 201. This 18- month multi-center, double-blind, placebo-controlled and parallel-group study of lecanemab enrolled 856 participants with mild cognitive impairment (MCI) due to AD and mild AD with confirmed presence of amyloid pathology from US, Europe and Asia. In this study, pre-specified analysis showed a consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses. In addition, the Phase III clinical study, AHEAD3-45, is currently evaluating lecanemab in people with preclinical AD. In March 2021, Eisai and Biogen completed enrolment of their Phase III Clarity AD study of lecanemab in people with mild cognitive impairment due to AD or mild AD dementia with confirmed amyloid accumulation in the brain. The study's primary endpoint is expected to be completed by the end of September 2022.
