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.”
Premium subscription required
Unlock this article along with other benefits by subscribing to one of our paid plans.