Eisai has started submitting data to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in support of an application for approval of its investigational lecanemab (BAN2401) to treat early Alzheimer’s disease. This submission followed the company’s prior assessment consultation with the PMDA, given in advance of an approval application and intended…

Lecanemab, an investigational antibody also known as BAN2401, has been granted a fast track designation from the U.S. Food and Drug Administration (FDA), which may help speed up its development for the treatment of early Alzheimer’s disease. The antibody, developed jointly by Biogen and Eisai, is…

The blood levels of two biomarkers of Alzheimer’s disease are significantly associated with changes in brain beta-amyloid deposits and cognitive function in early Alzheimer’s patients treated with lecanemab (BAN2401), according to a new analysis of data from a Phase 2b clinical trial. The results suggest that these blood…

Eisai has started work on a rolling submission to the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA) for lecanemab (BAN2401), its antibody treatment for early Alzheimer’s disease. As a rolling submission, Eisai will submit each portion of its application as it is completed,…

The University of Wisconsin School of Medicine and Public Health is recruiting participants for a Phase 3 trial that will test the efficacy and safety of lecanemab (BAN2401) in those who are at risk of developing symptoms of Alzheimer’s disease. The global AHEAD (NCT04468659) study seeks to…

Based on new evidence from an ongoing Phase 2b clinical trial, the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to lecanemab, also called BAN2401, an investigational antibody for treating early Alzheimer’s disease. The therapy, being developed jointly by Eisai and Biogen, is designed to…

Eisai and Biogen’s experimental therapy lecanemab (BAN2401) safely leads to rapid and sustained reductions in the brain levels of beta-amyloid — the protein that forms toxic clumps in Alzheimer’s — in people in early disease stages, according to one-year, preliminary data from a Phase 2 trial’s…

BAN2401, an experimental treatment for Alzheimer’s disease (AD), will be tested in the new global AHEAD 3-45 clinical trial, its developers have announced. The Phase 3 study — to be conducted in the U.S., Canada, Japan,…

Elenbecestat and BAN2401, two potential anti-amyloid therapies, were selected by the Alzheimer’s Clinical Trials Consortium (ACTC) to be evaluated in clinical studies aiming to prevent progression to early stages of Alzheimer’s disease.

The latest data from a Phase 2 trial (study 201) demonstrates that BAN2401 can slow cognitive decline, providing additional evidence of its potential as a disease-modifying therapy for Alzheimer’s disease, according to Eisai and Biogen, which are jointly developing the investigative therapy. BAN2401 is an engineered antibody…