2022-07-06| Trials & Approvals

Eisai and Biogen’s New Alzheimer’s Drug to Receive FDA Decision by January

by Reed Slater
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A year after the controversial decision to approve Biogen and Eisai’s Alzheimer’s disease (AD) drug, Aduhelm, the duo is on a similar track with their newer candidate, lecanemab, which the FDA granted Priority Review and will administer a decision by January 6, 2023. Eisai took the reigns for lecanemab’s regulatory approval process and the Phase 3 clinical trial, which could be the basis of the FDA’s Biologic License Approval decision. 


The Quest to Make Up For Aduhelm’s Shortcomings


Lecanemab, like Aduhelm, is a monoclonal antibody designed to bind to and neutralize toxic amyloid-beta aggregates, which are suspected to be a driving factor in the progression of AD. Eisai is testing the drug to treat patients with early AD, which can lead to memory loss and the inability to care for oneself. 

The two drugs developed under Eisai and Biogen’s partnership have similar mechanisms for treating AD, but lecanemab will have to prove its worth after Aduhelm has drawn so much criticism since its accelerated approval in June 2021. The FDA defined the primary endpoint of the Aduhelm trials as the reduction of amyloid-beta plaque in the brain. Despite only one of two late-stage studies demonstrating a slowing of cognitive decline, Aduhelm received approval for the first Alzheimer’s treatment in nearly twenty years. The FDA required Biogen to conduct a new controlled clinical trial to prove the drug’s efficacy, or it may withdraw its approval status. 

Since Aduhelm’s approval, criticisms have come raining down on the drug, preventing it from becoming the blockbuster hit Biogen and Eisai hoped it would be. The most recent blow to Aduhelm’s reputation came in April this year when the Centers for Medicare and Medicaid Services of the United States limited coverage of the drug to only patients participating in a clinical trial. This setback was followed by Biogen’s decision to withdraw a market application in Europe after a discussion with the European Medicines Agency revealed that current data would likely not be sufficient to convince the regulatory agency of Aduhelm’s safety and efficacy. 

The fallout from Aduhelm’s controversy has had an impact on Biogen’s reputation and its workforce. As a result of the poor performance, it has been reported that Biogen employees have been laid off, including two-thirds of Aduhelm’s commercial team and field leaders. 

Lecanemab is on a similar regulatory path as its predecessor after receiving Fast Track Designation and Breakthrough Therapy Designation. Now, Eisai and Biogen will have to rely on the findings of a Phase 3 clinical trial for the FDA to determine whether or not lecanemab meets primary endpoints and effectively treats Alzheimer’s safely.

With so many similarities in the lead-up to an approval decision between lecanemab and Aduhelm, interested parties worldwide are asking whether or not lecanemab has what it takes to become a successful Alzheimer’s treatment. 

Related article: Biogen Halts Aduhelm’s Second EU Marketing Application


The Race For an Effective, Profitable Alzheimer’s Treatment 


Alzheimer’s, at every stage of disease progression, has long-flummoxed neuroscientists, which makes creating a valuable treatment for the disease difficult. As some understanding of the underlying factors surrounding AD has become clearer, more companies are focusing on developing AD treatments. 

Roche and Eli Lilly are among the top competitors in the arena with drug candidates that also aim to capitalize on neutralizing amyloid-beta aggregates to slow AD progression. Gantenerumab, one of Genentech’s candidates, a subsidiary of Roche, has been in the works for several years. The company recently announced that it would begin a four-year Phase 3 clinical trial to study the long-term safety and efficacy of treating AD. 

Roche is working diligently to provide a safer, more effective treatment option, particularly after watching Aduhelm struggle from the sidelines. The company humbly announced that a different candidate, crenezumab, did not show significant improvements in participants. Roche also stopped a Phase 3 trial in 2014 when the treatment did not demonstrate positive results in participants. 

Eli Lilly continues developing its AD treatment candidate, donanemab, after receiving Breakthrough Therapy Designation in June last year. Like Roche, Eli Lilly is taking a slower approach as a side effect of Aduhelm’s rollout. The company will focus on more thorough clinical trials to provide more robust data before submitting a Biologic License Approval application. 

The Tokyo-based Eisai has a long history in the AD treatment space, with Aricept in its arsenal, a drug approved in 1996 to treat dementia of the Alzheimer’s type. Though groundbreaking at the time, Aricept does not show any promise of changing the progression of AD, as it hopes to demonstrate with lecanemab. 

Eisai and Biogen have all the momentum behind lecanemab that the companies could hope for with a drug candidate. Still, it is overshadowed by the problems associated with its predecessor, Aduhelm. Not only will Eisai and Biogen have to gain FDA approval, but the duo will also have to gain approval from the rest of the medical community to prove the safety and efficacy of lecanemab.


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