On December 16, 2021, Biogen and Eisai announced that they are expected to start a large confirmatory clinical trial in May next year to further evaluate Alzheimer's disease (AD) monoclonal antibodies Efficacy of therapy Aduhelm (aducanumab)
Aduhelm received accelerated approval from the US FDA in June of this year.
It is the first time the FDA has approved a new treatment for AD since 2003
Biogen plans to submit the final clinical trial plan to the FDA in March 2022.
If approved by the FDA, patient screening will be initiated in May 2022.
The main clinical endpoint will be evaluated 18 months after the start of treatment
Aducanumab is a monoclonal antibody that directly targets amyloid beta (Aβ)
The accumulation of Aβ in the brain is a clear pathophysiological feature of AD
Aducanumab is suitable for the treatment of patients with mild cognitive impairment due to AD or in the early stage of dementia (dementia).
These patients have confirmed the presence of Aβ deposits in the brain through PET scans
Aduhelm's approval in June was based on the accelerated approval channel
This channel is used to approve innovative therapies for the treatment of serious or life-threatening diseases
A statement issued by the FDA pointed out that Aduhelm’s accelerated approval is based on its impact on the surrogate endpoint, which consistently reduces the levels of amyloid plaque in the brains of patients in phase 3 clinical trials
However, the FDA also requires Bojian to conduct confirmatory clinical trials after obtaining accelerated approval to prove the clinical benefit of Aduhelm on the cognitive abilities of AD patients
Bojian’s press release pointed out that the trial will recruit more than 1,300 early-stage AD patients.
Other details of the trial design, including the trial endpoints, have not yet been disclosed
Based on previous experience, Bojian predicts that this test will take about 4 years to complete, which means that data may not be available until 2026 at the earliest
In addition, Bojian is waiting for the Phase 3 clinical trial data of another AD treatment drug, lecanemab, which is expected to be available in the middle of 2022
 Biogen Preps for Post-Approval Testing of Controversial Alzheimer's Drug.
Retrieved December 16, 2021, from https:// drug-aduhelm/
 All Approvals and Tentative Approvals December 2021.
Retrieved December 16, 2021, from https:// As Aduhelm faces doubts, Biogen plans another pivotal trial for 2022.
Retrieved December 16, 2021, from https:// -another-pivotal-trial-for-2022/