First New Alzheimer's Treatment In 18 Years Gets FDA Nod

ACROSS AMERICA — The first new treatment for Alzheimer's in nearly 20 years was approved for use by the Food and Drug Administration on Monday.

Aduhelm, the first therapy that targets the fundamental pathophysiology of the disease, got fast-track approval, the FDA said in a news release. The drug is made by the Cambridge, Massachusetts-based drug company Biogen. It's the first new Alzheimer's treatment approved by the FDA since 2003.

Research was conducted among 3,482 Alzheimer's patients, according to the FDA. The patients who received aduhelm saw an improved reduction of amyloid beta plaque, a "hallmark" of Alzheimer's, according to the FDA, while the control group in the research did not.

The FDA will require Biogen to conduct new randomized trials to verify the benefit, the FDA release states. Side effects noted during research include headaches, confusion, dizziness, vision changes and nausea.

The new drug, which Biogen developed with Japan’s Eisai Co., did not reverse mental decline, only slowing it in one study. The medication, aducanumab, will be marketed as Aduhelm and is to be given as an infusion every four weeks.

Dr. Caleb Alexander, an FDA adviser who recommended against the drug's approval, said he was “surprised and disappointed” by the decision.

“The FDA gets the respect that it does because it has regulatory standards that are based on firm evidence. In this case, I think they gave the product a pass,” said Alexander, a medical researcher at Johns Hopkins University.

The FDA's top drug regulator acknowledged that “residual uncertainties” surround the drug, but said Aduhelm's ability to reduce harmful clumps of plaque in the brain is expected to help slow dementia.

“The data supports patients and caregivers having the choice to use this drug,” Dr. Patrizia Cavazzoni told reporters. She said FDA carefully weighed the needs of people living with the “devastating, debilitating and deadly disease.”

The Associated Press contributed to this report.