New analysis of larger dataset showed that aducanumab has the potential to reduce clinical decline in people diagnosed with early Alzheimer’s disease

Aducanumab is an investigational human monoclonal antibody which has been studied for the treatment of early Alzheimer’s disease. Since October 2017 Biogen and Eisai have collaborated on the development and global commercialization of aducanumab. Biogen plans regulatory filling for aducanumab and aims at submitting a Biologics License Application in early 2020 (“Biogen Plans” 2019).

On 22 of October 2019 Biogen announced that it plans to initiate a regulatory approval procedure for aducanumab. Biogen’s primary goal is to offer aducanumab to people diagnosed with early Alzheimer’s disease who have previously been enrolled in clinical studies. The new analysis shows positive results which have chiefly been driven by significant exposure to high dose aducanumab in the larger dataset as compared to the data which was available at the point of time when the futility analysis was conducted (“Biogen Plans” 2019).

Alzheimer’s diagnosed people who received the treatment with aducanumab experienced noticeable benefits in the areas of cognition and function such as language, memory and orientation. Moreover, they shared experiencing significant advantages in conducting everyday activities such as arranging personal finances, doing household affairs such as doing the groceries, cleaning the house or doing laundry, and travelling outside of their house independently (“Biogen Plans” 2019).

RADAR-AD’s project leader - professor Dag Aarsland from King’s College London, comments:

“After the disappointing news earlier this year that US pharmaceuticals company Biogen and its Japanese partner Eisai had announced they would discontinue their global Phase 3 trial for aducanumab, a promising Alzheimer’s disease treatment, the news that subsequent analyses showed positive results are very encouraging. We do not yet have the full details and thus have to remain cautious, but it seems that those Alzheimer’s patients who received the highest dose had a significant slowing of decline. If this holds true, it will be the first drug to protect the brain against Alzheimer’s disease, which would be promising news for patients and families living with Alzheimer’s disease. This emphasises the need for new and more sensitive measurements of functional decline in early Alzheimer’s disease, which is the goal of RADAR-AD.”

In case of approval, aducanumab will become the first therapy which reduces the clinical decline in people diagnosed with Alzheimer’s disease (“Biogen Plans” 2019).

 

 

References:
“Biogen Plans Regulatory Filing for Aducanumab in Alzheimer’s Disease Based on New Analysis of Larger Dataset from Phase 3 Studies .” https://www.eisai.com/, 22 Oct. 2019, https://www.eisai.com/news/2019/pdf/enews201979pdf.pdf.