June 7, 2021
The U.S. Food and Drug Administration (FDA) today approved the human monoclonal antibody Aduhelm (aducanumab) for the treatment of Alzheimer’s disease. Designed to treat patients in the early stages of Alzheimer’s disease, Aduhelm selectively targets and removes beta amyloid plaques that are responsible for the progression of the disease. This is the first drug that targets the underlying pathology of Alzheimer’s disease rather than treating its symptoms.
Aduhelm was approved through the FDA’s Accelerated Approval pathway. This pathway gives approval for drugs that treat serious or life-threatening diseases and fulfill an unmet need, despite some uncertainty regarding their clinical benefits.
The FDA’s ruling comes after controversial results from clinical trials. In two phase III clinical trials, only one trial met the primary endpoint of the study: a reduction in clinical decline. However, both studies showed a significant decrease of beta amyloid plaques, which points to a probable reduction in clinical decline in the future.
The accelerated approval of Aduhelm is a potential win for patients with Alzheimer’s disease and their families. In this scenario, the possible benefits of the drug may well outweigh the risks.” said SNMMI President Alan Packard, PhD. “We are proud that nuclear medicine can help to support this drug by providing definitive information about the presence of amyloid in the brain and monitoring the effectiveness of the treatment by directly measuring amyloid removal."
More than six million Americans are living with Alzheimer’s disease, a number that is expected to grow as the population ages. It is the sixth leading cause of death among adults in the United States.
Aduhelm is manufactured by Biogen and Eisai Co., Ltd. The companies plan to distribute the drug globally.