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

Represents First to Come in Promising Alzheimer's Drug Pipeline

July 8, 2021 update: The FDA today approved updated prescribing information for aducanumab (Aduhelm™).  In its announcement, the drug manufacturer said, “Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease.” This change follows the science—and aligns with the patients who were studied in the drug’s phase 3 trials. This will focus the drug’s use in patients who have the potential to receive the most benefit.

June 7, 2021- Today’s FDA approval of the monoclonal antibody Aduhelm (aducanumab) to treat patients with Alzheimer’s disease reflects years of significant advances in Alzheimer’s research. This is the first new Alzheimer’s drug approved in 17 years and the first shown to modify the course of the disease, which FDA believes will lead to slowing of patients’ cognitive decline.

“Aducanumab is just the first of several Alzheimer's drugs that will become available in the next five to 10 years,” said Howard Fillit, M.D., Founding Executive Director and Chief Science Officer at the Alzheimer’s Drug Discovery Foundation (ADDF). “The robust Alzheimer’s research pipeline, complemented by a growing number of biomarkers and other important research tools, means that the clinical trials underway today are more rigorous and more promising than ever.”

The phase 3 aducanumab trials were among the first to use a validated biomarker test (the Amyvid PET scan) to ensure the right patients were enrolled and to measure the drug’s impact in the brain, according to Dr. Fillit.

Aducanumab works by clearing amyloid plaques in the brain—a hallmark of the disease. But amyloid buildup is just one of many important biological processes leading to the development and progression of Alzheimer’s. The Alzheimer’s Drug Discovery Foundation’s visionary approach to Alzheimer’s research, which is focused on the biology of aging, is now reflected in the diverse research pipeline. More than half of the 120 drugs currently in clinical trials are focused on a wide range of drug targets.

The ADDF clinical research portfolio, one of the largest in the world, invests in drugs targeting misfolded proteins like amyloid and tau, as well as inflammation, vascular problems, genetic alterations, and many other pathways that affect brain health. The ADDF also commits millions of dollars annually to support development of diagnostic biomarkers, including early support for the Amyvid PET scan and PrecivityAD (a blood test that came to market in 2020). The ADDF’s Diagnostics Accelerator is focused exclusively on supporting the development of novel biomarkers, which are essential to developing effective therapies.

“While today’s approval represents one step forward, neurodegenerative diseases rarely have just one cause,” said Dr. Fillit. “Like HIV and many cancers, the ultimate answer lies in having multiple drugs in our arsenal so we can combine them in different ways to provide patients with individualized treatments to meet their specific needs.”