Read the FDA’s decision letter on Biogen’s Alzheimer’s drug

The Food and Drug Administration campus in Silver Spring, Md. The agency announced a landmark decision on Monday, approving Biogen’s Alzheimer’s drug for use in the United States.Andrew Harnik

The Food and Drug Administration announced a landmark decision on Monday, approving Biogen’s Alzheimer’s drug for use in the United States.

Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, wrote in the agency’s decision letter that the approval is “significant in many ways.” The drug, which will be sold under the brand name Aduhelm, is the first new medicine approved for the fatal disease in 18 years, and is the only approved Alzheimer’s therapy that targets underlying processes of the disease, while other medicines treat its symptoms.

The FDA approved Aduhelm using the Accelerated Approval pathway, which allows it to clear drugs that are likely to result in a benefit for patients, but where there still remains some uncertainty. The agency asked Biogen to conduct a larger clinical trial to show that the drug’s goal — removing a sticky plaque that builds up inside the brain of Alzheimer’s patients — results in benefits to patients.

“We are well-aware of the attention surrounding this approval,” Cavazzoni wrote, referring to the public debate over the controversial drug. “At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward.”

Read the rest of the FDA decision: