Japan-based Eisai Co., Ltd (TYO: 4523) and its US co-development partner Biogen Inc. (NASDAQ: BIIB) have revealed that Eisai has initiated a Biologics License Application (BLA) in China for lecanemab, their innovative Alzheimer’s disease therapy. The filing is supported by data from the Phase II Study 201 trial in mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD with confirmed amyloid beta accumulation in the brain. Eisai is also supplying top-line data from the global Phase III Clarity AD study, with full data to be provided as it becomes available and in communication with China’s National Medical Products Administration (NMPA).
Mechanism of Action and Clinical Data
Lecanemab is an anti-amyloid beta (Aβ) protofibril antibody that selectively binds and eliminates soluble, toxic amyloid beta aggregates (protofibrils) thought to contribute to neurotoxicity in AD. The mechanism of action targets an earlier stage of the amyloid deposition process than other amyloid-beta targeted therapies. Clinical trials have shown that lecanemab treatment resulted in a dose-dependent, longitudinal, and significant reduction in amyloid-beta accumulation in the brain compared to placebo. At 18 months, the molecule produced a reduction in clinical decline based on three scores of severity of dementia or cognitive decline: ADCOMS, CDR-SB2, and ADAS-cog, with suppression rates of 29.7%, 26.5%, and 47.2% in the 10 mg/kg bi-weekly treatment group, respectively. However, the study did not achieve its primary outcome measure at 12 months of treatment.
Adverse Events and Global Filings
The most common adverse events in the 10 mg/kg bi-weekly group (incidence ≥ 5% and more frequent than in the placebo group) were infusion reactions (19.9%), headache (13.7%), ARIA-E (9.9%), cough (8.7%), diarrhea (8.1%), dizziness (7.5%), and microhemorrhages (5.6%). Notably, China is the second major market where Eisai has initiated the market approval process, following a filing to the US FDA in July 2022 under the accelerated approval pathway, with a regulatory decision expected on January 6, 2023. The drug has Breakthrough Therapy and Fast-Track designations in the US. Further filings are expected in Japan and Europe by the end of Q1 2023.-Fineline Info & Tech
