Alzheimer’s Drug Discovery Foundation Statement on Biogen Filing of Aducanumab for FDA Approval

Biogen has submitted an application to the FDA seeking approval of aducanumab. If approved, aducanumab would be the first treatment to show that reduction in amyloid plaques in the brain slows cognitive decline in patients with early stage Alzheimer’s and potentially helps them maintain their ability to complete activities of daily living.

“I’m looking forward to learning more about the data included in Biogen’s application as the FDA proceeds with its review,” said Howard Fillit, MD, Founding Executive Director and Chief Science Officer at the ADDF.

Dr. Fillit says the Biogen study itself is a landmark trial because it is one of the first to use amyloid PET imaging (Amyvid™) as a biomarker to enroll patients. “The ADDF was an early investor in Amyvid and our Diagnostics Accelerator continues to support cutting edge research to develop other non-invasive biomarkers, such as blood tests, for Alzheimer’s disease. As the field develops more diverse, novel drug targets beyond beta amyloid and tau, we need to expand our arsenal of related biomarkers.”

No matter what happens with aducanumab, the ultimate goal is to develop drugs that work on many different pathways, including those beyond amyloid, that are implicated in Alzheimer’s disease. There are more than 100 drugs currently in clinical trials that address novel targets including misfolded proteins, inflammation, vascular problems, genetic mutations and age-related changes associated with Alzheimer’s.

Alzheimer’s is a complicated disease and a combination of drugs addressing multiple targets will be needed to effectively treat it. Still, Dr. Fillit recognizes the importance of today’s filing. “If the data bear out, aducanumab could potentially help the millions of Americans living with mild cognitive impairment and early dementia today.”