Eisai and Biogen Seek FDA Accelerated Approval for Alzheimer’s Drug Lecanemab

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Recently, Biogen and Eisai are actively pursuing U.S. Food and Drug Administration (FDA) approval for their second Alzheimer's disease drug, lecanemab (BAN2401).

In its latest quarterly earnings report, Eisai stated that the two companies have initiated discussions with the U.S. FDA to determine the "optimal regulatory pathway" for the approval of lecanemab. The drug is an investigational anti-amyloid beta protofibril antibody that was granted Breakthrough Therapy designation this June after demonstrating potential for the treatment of Alzheimer's disease. The U.S. FDA granted lecanemab this designation to accelerate the development and review of drugs for serious or life-threatening conditions.

The drug was initially co-developed by Eisai and BioArctic. In March 2014, Eisai and Biogen entered into a collaboration to co-develop lecanemab. The drug is an anti-Aβ protofibril antibody with a mechanism of action similar to Aduhelm, designed to reduce the accumulation of amyloid plaques in patients' brains. Ivan Cheung, Head of Neurology at Eisai, stated in his presentation, "Following the FDA Breakthrough Therapy designation, Eisai has initiated communications with the FDA to optimize and accelerate the regulatory pathway for lecanemab. Eisai will explore all options with the FDA and seek regulatory recommendations, including those pertaining to the accelerated approval pathway."

The U.S. FDA granted Breakthrough Therapy designation to lecanemab, primarily based on the positive results from the Phase IIb clinical trial, Study 201. Trial results demonstrated that lecanemab at the highest dose (10 mg/kg) significantly reduced amyloid levels in patients' brains. Furthermore, patients who initially received placebo and were switched to lecanemab during the extension phase also exhibited reduced amyloid levels. The trial enrolled 856 patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease (AD) with confirmed amyloid pathology. Results showed sustained clinical improvement across multiple clinical and biomarker endpoints at the highest dose. Additionally, lecanemab demonstrated favorable tolerability in the trial, with an incidence rate of amyloid-related imaging abnormalities (ARIA), edema, and effusions of 9.9% at a dose of 10 mg/kg administered every two weeks.

In July, Biogen and Eisai announced the initiation of the Phase III AHEAD 3-45 trial in the United States to evaluate the efficacy of lecanemab in early Alzheimer’s disease patients who are asymptomatic but exhibit elevated brain amyloid levels, with approximately 1,795 subjects enrolled. Eisai and Biogen completed the trial registration in March 2021, and the study’s primary endpoint is expected to be reached by the end of September 2022. Jointly funded and conducted by the National Institute on Aging (NIA) at the U.S. National Institutes of Health (NIH) and Eisai, the trial will be carried out in the United States, Japan, Canada, Australia, Singapore, and Europe.

Although Eisai and Biogen are seeking FDA accelerated approval for lecanemab, the first approved Alzheimer’s disease drug, Aduhelm, remains mired in ongoing controversy. In June of this year, Aduhelm, developed by Biogen and Eisai, received FDA approval, becoming the first Alzheimer’s disease treatment approved in the United States in nearly two decades. However, the drug has faced strong criticism from both the market and the academic community due to widespread skepticism regarding insufficient evidence of efficacy, non-standard approval procedures, and excessively high drug pricing.

Source: Eisai and Biogen Gun for Speedy Approval for Another Alzheimer's Drug