A major reshuffling at the FDA opened the road for Biogen’s Alzheimer’s drug. Can it cross the finish line?
All things considered, Biogen has walked a relatively easy road to next Monday’s approval decision for its controversial Alzheimer’s drug aducanumab.
After flunking a Phase III trial, the company officially pulled the plug on the drug a little more than two years ago, dashing any hopes that another trial might prove offer proof that this potential drug actually worked.
But then in October 2019, Biogen pulled a surprising about-face, deciding to revive the drug while noting, “Following discussions with the FDA, Biogen plans to submit a regulatory filing in early 2020.” The company now claimed that the original “futility analysis was incorrect,” and that “aducanumab reduced clinical decline in patients with early Alzheimer’s disease.”
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