Eisai launched the medium-term business plan “EWAY Future & Beyond” in April 2021. Eisai will endeavor to make steady contributions to patients with goals going forward to accomplish in the medium- to long-term, as a pharmaceutical company that develops new drugs in the long-term.
As for research and development under “EWAY Future & Beyond”, through the evolution of biomarkers, we will shift from diagnosis based on symptoms and/or tumors to disease continuum analysis based on pathophysiology, and we will aim for the provision of precision medicine. In neurology, with regard to Alzheimer’s disease (AD), we will realize continuous brain health panel diagnosis, which makes quantitative and continuous measurements of pathophysiological biomarkers for precise diagnosis of each person’s stage within the disease continuum and aim to realize provision of optimal treatment (drug or non-drug) in which drugs are determined based on precise diagnosis.
Neurology Area–Contribution to patients by next-generation dementia treatments
Regarding lecanemab (development code: BAN2401)＊1,2, an investigational anti-amyloid beta (Aβ) protofibril antibody, Eisai has completed a rolling submission of a Biologics License Application under the accelerated approval pathway for early AD in the United States in May 2022. A pivotal Phase Ⅲ study (Clarity AD study) in early AD is steadily ongoing and the readout of the primary endpoint is targeted for fall of 2022. Eisai plans to submit for full approval of lecanemab during fiscal year 2022 in the United States based on this clinical study result. Eisai also aims to submit new drug applications in Japan and Europe during fiscal year 2022 based on this clinical study result. Also, patient enrollment is progressing steadily in a Phase Ⅲ study (AHEAD 3-45) for preclinical (asymptomatic) AD based on joint research with the ACTC＊3.
＊1 Co-development with Biogen Inc. ＊2 Investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic ＊3 Alzheimer’s Clinical Trials Consortium