Biogen to pursue FDA regulatory approval for investigational drug aducanumab

Reviewed by Kate Anderton, B.Sc. (Editor)Oct 22 2019

On behalf of the more than 5 million Americans living with Alzheimer's and their family members, the Alzheimer's Association is encouraged to learn that Biogen will pursue regulatory approval from the FDA for the investigational drug aducanumab based on Phase 3 clinical trial results from the EMERGE and ENGAGE studies, and other related data, after finding a reduction of cognitive and functional decline in people taking the high dose.

Founded by caregivers, and focused on creating a world without Alzheimer's and all dementia, the Alzheimer's Association is an organization that puts the person with dementia and family members first. At the same time, we believe in and are driven by scientific evidence. We eagerly anticipate reviewing a full report of the findings from these studies and participating in a robust discussion of data.

In March, Biogen announced it would discontinue its Phase 3 clinical trials for aducanumab after an interim analysis showed the drug was not likely to produce a meaningful benefit. However, an analysis including an additional three months of data will be submitted to the FDA. While under review by the FDA for possible approval, the company says it plans to offer access to aducanumab to eligible participants previously enrolled in the Phase 3 studies, the long-term extension of the Phase 1b study, and a safety study.

No stone can be left unturned. We must advance all potential treatment avenues and also explore methods for combining these approaches. Alzheimer's and other dementias are complex, and their effective treatment and prevention will likely also be a complex - but achievable - task. All currently pursued treatments that are considered safe should be continued to determine their efficacy.

The Alzheimer's Association has been involved in every major advancement in Alzheimer's and dementia research since the 1980s, and is the world's largest nonprofit funder of Alzheimer's and dementia research. The Alzheimer's Association directly funds science and unites the scientific academic, government and industry leaders worldwide to accelerate research. A few examples include:

• The Alzheimer's Association International Conference (AAIC), the world's largest and most influential international meeting dedicated to advancing dementia science.

• Our Part the Cloud program has invested over $30 million to advance more than 30 clinical trials. These studies are targeting a wide variety of known and potential new aspects of the disease, such as inflammation and other promising new targets for therapy.

• And, leadership of the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER); the first study of multi-component lifestyle interventions to protect cognitive function in a large-scale U.S.-based population.

• The Alzheimer's Association, the Alzheimer's Impact Movement (AIM) and dedicated volunteers have advocated to propel the U.S. government to rise to the growing challenge of Alzheimer's, resulting in a five-fold Alzheimer's research funding increase since the passage of the National Alzheimer's Project Act (NAPA) -- today, funding for Alzheimer's and dementia research at the National Institutes of Health (NIH) is $2.4 billion.

At the Alzheimer's Association, we have never been as optimistic as we are today.