“Today FDA approved Aduhelm (aducanumab) to treat patients with Alzheimer’s disease using the Accelerated Approval pathway, under which the FDA approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments,” the agency said in a statement.
The FDA noted that approval is typically given for drugs likely to produce favourable outcomes when some uncertainty remains about their clinical benefits.
Aduhelm was the first novel therapy approved for Alzheimer’s disease since 2003 and was directed at the underlying pathophysiology of the disease, precisely at the presence of amyloid-beta plaques in the brain, the FDA said.
“The clinical trials for Aduhelm were the first to show that a reduction in these plaques - a hallmark finding in the brain of patients with Alzheimer’s - is expected to lead to a reduction in the clinical decline of this devastating form of dementia,” the agency said.
The FDA acknowledged the attention surrounding its approval of the drug in view of the fact the data submitted for review of Aduhelm was highly complex and the expert community had differing views on its benefits.
“As a result of FDA’s approval of Aduhelm, patients with Alzheimer’s disease have an important and critical new treatment to help combat this disease,” it said. “The need for treatments is urgent: right now, more than 6 million Americans are living with Alzheimer’s disease and this number is expected to grow as the population ages. Alzheimer's is the sixth leading cause of death in the United States.”
On average, a person with Alzheimer’s disease lives four to eight years after being diagnosed, but some patients have lived up to 20 years, the FDA noted.