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2022-05-10| Trials & Approvals

Eisai to File Another Biogen-Partnered Alzheimer’s Drug After Confidence Hit

by Fujie Tham
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After being granted a fast-track label by the FDA in late-2021, Eisai and Biogen have completed the rolling submission for their next Alzheimer’s therapeutic – lecanemab. Japanese Eisai will oversee the regulatory process this time, following Biogen’s bumpy Aduhelm led.

Lecanemab, both companies’ follow-up to Aduhelm, is an anti-amyloid beta protofibril antibody, designed to treat mild cognitive impairment due to Alzheimer’s. If FDA accepts its Biologics License Application (BLA), Eisai could receive a response from the FDA in under 6 months instead of 10. 

FDA agreed that the currently running ​​Clarity AD Phase III study, when completed, can serve to verify clinical benefits of lecanemab. Relying upon trial results, Eisai may submit for full approval of lecanemab to the FDA in the 2022 fiscal year, despite the doubtful watchers who witnessed the latest European withdrawal in addition to a series of controversies. 

Related article: From Forbidden Drugs to Psychotropic Cures: A “Psychedelic Boom” Breaks New Ground in Treating Mental Illnesses

 

Rough Marketing Journey for Alzheimer’s Therapeutics

 

Since the US marketing approval of Aduhelm in 2021, Biogen anticipated blockbusting sales of tens of billions of dollars, but ended up in a dispute with the US Centers for Medicare & Medicaid Services (CMS), huge layoffs, and last month’s withdrawal from Europe. Earlier this week, Biogen decided to replace its CEO and cut Aduhelm’s budgets, only retaining minimal resources to make Aduhelm available to current US Alzheimer’s patients to save $500M annually.

Unlike Aduhelm which regulators argued against for its unconvincing effectiveness, the duo already started their vital lecanemab Clarity AD Phase III study to address doubts on clinical effectiveness. However, lecanemab will still need the CMS’s coverage greenlight to reach patients across the US.

Multiple players are gaining on Alzheimer’s drugs, Eli Lilly, Eisai, Roche, Diadem, and ProMis Neurosciences have medications in multiple development stages. Roche’s Genentech and Eli Lilly are working hard to advance the final clinical phase of their anti-amyloid drugs. In particular, Eli Lilly has high expectations for its Donanemab, which also received expedited approval from the FDA, and Genentech indicated that it will follow the standard FDA review process and expects to reveal clinical data in late 2022.

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