Biogen and Japan’s Eisai announced that the US FDA granted an expedited review for the marketing application of their potential blockbuster Alzheimer’s drug, aducanumab.
If approved, aducanumab would be the first treatment designed to delay progression of the fatal disease, but its path to approval has not been without controversy. Biogen originally abandoned its quest to seek approval for drug in March 2019 after releasing data from two late-stage trials. The results on patients with early or mild Alzheimer’s were iffy — in one study, patients who received a high dose scored better on a dementia scale. Then in a second phase 3 trial, those same patients fared worse compared to those on a placebo. Ultimately, the mixed results, along with a failed futility analysis, caused Biogen to end the research.
Then in October 2019, Biogen made a surprise announcement that a reanalysis of the data revealed that aducanumab was effective at a high dose over an extended period of time. The company then said it would pursue FDA approval, which it did in July of this year.
Now, with a priority review designation attached to the drug, the agency is expected to make a decision by March 7, 2021.
Read the press release
