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, in September 2022, the Phase III Clarity AD study for early Alzheimer's disease (early AD) met its primary endpoint and all key secondary endpoints with highly statistically significant results. The adverse event associated with anti-amyloid antibodies, amyloid-related imaging abnormality incidence profile, was also within expectations.
In the U.S., lecanemab was granted accelerated approval as a treatment for Alzheimer’s disease by the U.S. Food and Drug Administration (FDA) on January 6, 2023. On the same day, Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway, which was granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. In Europe, Eisai submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023.
In Japan, Eisai submitted a MAA to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023, which was granted Priority Review.
In China, Eisai initiated submission of data for BLA to the National Medical Products Administration (NMPA) of China in December 2022, which was granted Priority Review.
Development of subcutaneous injection formulation is underway to enhance convenience for patients. In addition, a study to determine a new dosing regimen for maintenance treatment after removal of brain Aβ is also underway.
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