FDA Greenlights Biogen Alzheimer’s Drug Aducanumab Amidst Debate

The FDA has officially approved aducanumab, Biogen’s drug for Alzheimer’s Disease, the agency has announced. This marks the first Alzheimer’s drug in nearly 20 years, and the first one to address cognitive decline in those with the illness.

FDA approved the drug, which is being marketed as Aduhelm, under the agency’s Accelerated Approval pathway.

“Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003,” Dr. Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research, wrote in the announcement.

“Perhaps more significantly, Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain.  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.”

This comes after long speculation about the drug’s efficacy. Biogen pulled the drug in 2019 after some trials showed it may not have much of an effect, but ultimately reversed course and announced it would submit Aduhelm for approval after all.

Outside experts have also called some of the trial data from Aduhelm “unconvincing.”

But the FDA and other stakeholders have also faced immense pressure from patients and patient advocates to approve the drug.

“We are well-aware of the attention surrounding this approval,” Cavazzoni said. “We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested stakeholders. With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review.”