FDA approves controversial new Alzheimer’s drug
The U.S. Food and Drug Administration (FDA) approved a new drug to treat patients with Alzheimer’s disease, the first in nearly two decades, according to an announcement made by the agency last week.
The drug, Aduhelm (aducanumab), a monthly intravenous infusion, was approved using the Accelerated Approval pathway, which allows the FDA to approve a drug for a serious life-threatening disease that may provide more therapeutic benefit than existing treatments and shows an effect on a surrogate endpoint, even if some uncertainty remains. It works by targeting amyloid beta plaques in the brain.
The approval has garnered a lot of attention. Practitioners in the integrative medicine community have expressed concerns, including some of the side effects experienced by trial participants.
Dale Bredesen, MD, creator of the Bredesen Protocol, said in an interview with CBN News, that amyloid plaque is simply a barrier protecting the brain from attacks. The amyloid plaque is a response to the disease, he said, and getting rid of the plaques does not get rid of Alzheimer’s disease.
Bredesen told reporters that the best way to reverse the disease is by identifying and addressing the things that are attacking the brain.
The FDA said in its statement that it recognizes the attention and possible controversy around the approval.