Biogen and Eisai to Launch Confirmatory Clinical Trial to Further Evaluate Aduhelm in Alzheimer’s Disease

On December 16, 2021, Biogen and Eisai announced that they are expecting to initiate a large confirmatory clinical trial in May next year to further evaluate the efficacy of Aduhelm (aducanumab), a monoclonal antibody therapy for Alzheimer's disease (AD). Aduhelm received accelerated approval from the U.S. FDA in June this year, marking the first new AD treatment approved by the FDA since 2003. Biogen plans to submit the final protocol of the clinical trial to the FDA in March 2022, and if approved by the FDA, patient screening will commence in May 2022, with the primary clinical endpoint assessed 18 months after the start of treatment.

Aducanumab is a monoclonal antibody that directly targets amyloid-beta (Aβ). The aggregation of Aβ in the brain is a definitive pathophysiological characteristic of AD. Aducanumab is suitable for treating patients with mild cognitive impairment due to AD or those in the early stages of dementia, confirmed by PET scans to have Aβ deposits in the brain.

Aduhelm's approval in June was based on the Accelerated Approval pathway. This pathway is used to approve innovative therapies for serious or life-threatening diseases. The FDA's statement noted that Aduhelm's Accelerated Approval was based on its effect on a surrogate endpoint, consistently reducing levels of amyloid plaque in patients' brains during phase 3 clinical trials. However, the FDA also required Biogen to conduct confirmatory clinical trials after receiving Accelerated Approval to demonstrate Aduhelm's clinical benefit on cognitive abilities in AD patients.

Biogen's press release noted that this trial will recruit over 1,300 patients with early-stage AD. Other details of the trial design, including the endpoints, have not yet been disclosed. Based on previous experience, Biogen expects the trial to take approximately four years to complete, meaning data may not be available until at least 2026. Additionally, Biogen is awaiting phase 3 clinical trial data for another AD treatment drug, lecanemab, which is expected to be available by mid-2022.

References:

[1] Biogen Preps for Post-Approval Testing of Controversial Alzheimer's Drug. Retrieved December 16, 2021, from https://www.biospace.com/article/biogen-outlines-post-approval-trials-of-alzheimer-s-drug-aduhelm/

[2] All Approvals and Tentative Approvals December 2021. Retrieved December 16, 2021, from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process

[3] As Aduhelm faces doubts, Biogen plans another pivotal trial for 2022. Retrieved December 16, 2021, from https://www.statnews.com/2021/12/16/as-aduhelm-faces-doubts-biogen-plans-another-pivotal-trial-for-2022/

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