Update on the DIAN-TU-001 Trial with E2814 and Lecanemab (Eisai Co., Ltd)
January 7, 2023
The statement below is in response to Eisai’s 06 January 2023 announcement regarding the FDA’s accelerated approval of lecanemab for the treatment of symptomatic Alzheimer’s disease (AD).
On January 6th, 2023, the FDA announced approval of lecanemab (an anti-amyloid beta (Aβ) protofibril antibody) through its Accelerated Approval Program for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain.
DIAN-TU recognizes the importance of this approval for patients with Alzheimer’s disease symptoms. Eisai and the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) at Washington University in St. Louis, Missouri have previously announced a collaboration to include lecanemab in the DIAN-TU Tau NexGen trial to be tested with E2814 – an experimental immunotherapy targeting the microtubule binding domain of the tau protein.
“This approval is a very important step forward in the treatment of Alzheimer’s disease. Our partnership with Eisai to include lecanemab in our combination trial will continue to move the field forward,” said principal investigator Randall J. Bateman, MD, the Charles F. and Joanne Knight Distinguished Professor of Neurology and the director of DIAN-TU.
The DIAN-TU NexGen trial of E2814 and lecanemab is currently recruiting participants [Clinicaltrials.gov NCT05269394].Categories: DIAN-TU Announcement