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Biogen was founded in 1978 as one of the world’s first global biotechnology companies by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp, Biogen has led innovative scientific research with the goal over the last decade to defeat devastating neurological diseases.
If the U.S. Food and Drug Administration (FDA) wants to approve the first new drug for Alzheimer’s disease in 17 years, it will have to do so against the overwhelming recommendation of the experts it turned to for advice on the matter. An independent advisory panel convened by the agency today to review data on the antibody drug candidate, called aducanumab, concluded that even the strongest available clinical trial data don’t support its effectiveness.
FDA, which is expected to decide about aducanumab by March 2021, doesn’t have to follow the advice of its advisory committees, but it typically does. If approved, aducanumab would be the first Alzheimer’s drug prescribed to slow cognitive decline and would likely bring in tens of billions of dollars in sales for its developer, Biogen. It might also vindicate the battered theory that clearing the brain of the sticky protein called beta amyloid can effectively treat the disease.
During a public comment section of the meeting, people with Alzheimer’s— including some who participated in Biogen studies—and their caregivers strongly urged FDA to approve the drug. But many researchers, including most of the advisory committee members, weren’t convinced by the two large clinical trials of aducanumab—only one of which found evidence of benefit. And the committee was uncomfortable with rosy interpretations of Biogen’s data that FDA presented today and in documents it released this week.
“Alzheimer’s treatment is a huge, urgent, unmet need, but I also think if we approve something where the data is not strong, we have a risk of delaying good treatment,” said Joel Perlmutter, a neurologist at Washington University in St. Louis who is one of 11 voting members of the committee, which included physicians, biostatisticians, a patient representative, and a health care administrator.
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