Eisai and Biogen Seeking Speedy Approval for Another Alzheimer’s Drug

 

Massachusetts-based biotechnology firm Biogen and its Tokyo-based partner Eisai are seeking a speedy approval from the U.S. Food and Drug Administration (FDA) for its second Alzheimer’s disease drug, lecanemab. 

In its latest quarterly earnings presentation, Eisai said that they have initiated communication with the FDA to achieve “the most optimal regulatory pathway” for lecanemab (BAN2401). The drug, an investigation anti-amyloid beta protofibril antibody, was given a Breakthrough Therapy designation in June after showing promise as a treatment for Alzheimer’s disease. The FDA awards this designation to expedite the development and review of medicines for severe or life-threatening conditions. 

The request comes on the heels of the approval of Aduhelm in June, also known as aducanumab, which functions similarly to lecanemab in reducing the buildup of amyloid beta plaques in patients brains. 

In the presentation, Eisai said Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia disease stages, which were the subjects of its clinical trials. The companies are seeking the continued approval for Aduhelm as a treatment for AD, which is still contingent upon verification of clinical benefits in confirmatory studies. 

At present, lecanemab is undergoing Phase III of AHEAD 3-45 trials, with some 1,795 subjects enrolled. Preliminary data reportedly show that it is feasible to identify participants across the continuum of AD who are at risk for amyloid accumulation and cognitive decline for trials targeting underlying AD pathology. 

Eisai and Biogen completed the enrollment process in March 2021, and the study’s primary endpoint is expected to be achieved by the end of September 2022. 

“Under the breakthrough therapy designation from the FDA we have initiated communications with theFDA to seek the most optimal and expedited regulatory pathway forward for lecanemab. We will explore all options with the FDA, we will listen to their advice, including the accelerated approval pathway,” said Ivan Cheung, neurology chief at Eisai, in its presentation. 

Lecanemab works by selectively binding to neutralized and eliminate soluble, toxic protofibrils that contribute to the neurodegenerative process. With that condition, it may have the potential to affect disease pathology and slow down the progression of AD. 

Eisai obtained the global rights to study, develop, manufacture, and market lecanemab. In March 2014, the Japanese firm partnered with Biogen to develop and commercialize the drug upon approval. AHEAD 3-45 is a collaboration project with the Alzheimer’s Clinical Trial Consortium and is funded by Eisai and the National Institute on Aging.