Biogen’s Alzheimer’s Drug Gets FDA Approval, Mixed Reviews

A lackluster performance in clinical trials of the monoclonal antibody aducanumab has left some experts unconvinced of its benefit.

Written byKerry Grens

| 2 min read

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Update (July 8, 2021): The US Food and Drug Administration has narrowed the indication for aducanumab to patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease, according to a statement from Biogen.

Update (June 14): Three members of the US Food and Drug Administration advisory committee that recommended against the approval of aducanumab have resigned in protest, according to The New York Times: Joel Perlmutter of Washington University School of Medicine, David Knopman of the Mayo Clinic, and Aaron Kesselheim of Harvard Medical School and Brigham and Women’s Hospital.

The US Food and Drug Administration has approved aducanumab, a monoclonal antibody going by the brand name Aduhelm, to treat Alzheimer’s disease in early-stage patients. The announcement today (June 7) marks the first time in 17 years that the FDA has approved a drug to treat the neurodegenerative disease.

“After so many disappointments in ...

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Meet the Author

Kerry Grens
Kerry served as The Scientist’s news director until 2021. Before joining The Scientist in 2013, she was a stringer for Reuters Health, the senior health and science reporter at WHYY in Philadelphia, and the health and science reporter at New Hampshire Public Radio. Kerry got her start in journalism as a AAAS Mass Media fellow at KUNC in Colorado. She has a master’s in biological sciences from Stanford University and a biology degree from Loyola University Chicago.
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