Aducanumab, a drug by Biogen went through two randomized...

Aducanumab, a drug by Biogen went through two randomized double-blind studies. One was a high dose study, whilst the other was for lower doses. Both trials were stopped by a data regulator because the data indicated the results would not be clinically significant for the indication (mild Alzheimer's disease).

In 2019 Biogen found "more data" from the cancelled trials that showed that high doses may be effective and applied to have the FDA approve the drug to be used at the highest dose. The data they found was from one of the studies only (the lower dose study), and the higher dose study actually showed worse outcomes VS placebo.

The advisory board to the FDA voted 10 no, 1 abstention and 0 (zero) yes. Yet, the FDA approved the drug under the accelerated approval pathway.

From google - Aduhelm is approved under the accelerated approval pathway, which provides patients with a serious disease earlieraccess to drugs when there is an expectation of clinical benefit despite someuncertainty about the clinical benefit.