ESALY - Biogen and Eisai win FDA's Breakthrough Therapy tag for Alzheimer's drug lecanemab

Biogen (BIIB) and Eisai (ESALF), (ESALY) announced that the FDA granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational humanized monoclonal antibody for Alzheimer's disease ((AD)).Breakthrough Therapy designation aimed to accelerate the research work and review of treatments targeting serious or life-threatening conditions enables the developer to receive intensive guidance from the FDA with potential eligibility for priority review.Lecanemab targeting amyloid beta (A?) is undergoing a Phase 3 clinical study, AHEAD 3-45, in individuals with preclinical AD. In March, the two companies completed the enrollment for the Clarity AD study involving patients with early AD.The regulator’s decision on lecanemab was based on recently published results of a Phase 2b clinical trial (Study 201) which involved 856 patients with mild cognitive impairment ((MCI)) due to AD and mild AD.

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Biogen and Eisai win FDA’s Breakthrough Therapy tag for Alzheimer’s drug lecanemab