Biogen and Eisai Alzheimer’s Drug Shows Positive Results in Phase 3 Trial

Partners Eisai and Biogen announced positive topline results from Eisai’s Phase 3 clinical trial of lecanemab, an investigational drug for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease. Lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results. Eisai plans to discuss the data with regulatory authorities in the U.S., Japan and Europe with the aim of filing for traditional approval in the US and for marketing authorization applications in Japan and Europe by March 31, 2023. Additionally, Eisai will present the study results in November, 2022, at the Clinical Trials on Alzheimer’s Congress (CTAD), and publish the findings in a peer-reviewed medical journal.

“Today’s announcement gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer’s disease, and provide a clinically meaningful impact on cognition and function,” said Biogen CEO Michel Vounatsos. “Importantly, the study shows that removal of aggregated amyloid beta in the brain is associated with a slowing of disease in patients at the early stage of the disease. In a related statement, Eisai CEO Haruo Naito went a step further stating that the “study results prove the amyloid hypothesis, in which the abnormal accumulation of beta amyloid in the brain is one of the main causes of Alzheimer’s disease.”

Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. (Source: Biogen Website, 27 September, 2022)