It’s been touted as a “game changer” and ultimately deemed a “failure,” but now it’s getting a second chance.
Aducanumab, a much-hyped treatment for Alzheimer’s disease that was seemingly abandoned earlier this year after a review committee doubted its effectiveness, will be submitted to the FDA after all. That’s according to Biogen, the drug’s creator, which has announced plans to seek regulatory approval of Aducanumab sometime early next year.
The sudden change of plans has left health-industry commentators stunned, with STAT News calling it a “shocking reversal.” It’s also been major shot in the arm for Biogen’s bottom line, with its stock skyrocketing as high as 40% in early trading, as CNBC reported.
So what happened? According to a 17-page update to investors released by Biogen earlier today, the company says it is now confident in the drug’s effectiveness based on a new analysis of an even larger data set. Here are the key points from the update’s summary:
- “Following discussions with the FDA, Biogen plans to submit a regulatory filing in early 2020.”
- “The futility analysis in March 2019 was based on a smaller, earlier dataset with less exposure to high dose aducanumab. The result of the futility analysis was incorrect.”
- “New analysis of larger dataset showed that aducanumab reduced clinical decline in patients with early Alzheimer’s disease as measured by the pre-specified primary and secondary endpoints.”
- “The positive results of this new analysis were driven primarily by greater exposure to high dose aducanumab in the larger dataset.”
- “If approved, aducanumab would become the first therapy to reduce clinical decline in Alzheimer’s disease.”
The change of course is also sparking its share of skepticism, with Bloomberg health columnist Max Nisen calling it a “risky gambit” and saying investors should be cautious. For now, you can read Biogen’s full update (complete with flowcharts and extensive data analyses) here.