Biogen Inc. (NASDAQ:BIIB) saw a dramatic stock upswing with its market values reaching over $15 billion after the FDA seemed to be supportive of its controversial Alzheimer’s drug.
Aducanumab first Alzheimer’s’ disease drug for slowing progression
Aducanumab will be the first medicine to receive approval for slowing progression of memory loss rather than just treatment of symptoms this making it a guaranteed blockbuster. However, the promise comes with some controversy considering the company had stopped two identical trials in 2019 terming them as failures but later resurrected one trial as a success after reanalysis.
On Wednesday the FAD released a favorable review of aducanumab against this backdrop. The news sent Biogen stock surging over 40% adding to the over $15 billion valuations of the company. Although there is a need to be optimistic about Alzheimer’s disease therapy, approval of the drug will be a mistake. This will substantially lower the FDA’s standards when the regulator ought to do the opposite.
Divided opinion regarding the effectiveness of aducanumab
The company had plenty of excuses regarding the mixed results in the two studies, even though they were similar. For instance, Biogen suggests that the failed study was disproportionately impacted by a small group of subjects with rapidly progressing AD. Despite hitting a setback, the company labelled the study supportive after collection and analyzing additional data. It seems the FDA is in agreement with the unprecedented revival and would likely approve aducanumab making it the first drug to receive approval for slowing progression of AD.
However, there is divided opinion among researchers on whether or not aducanumab works as the company claims. In its briefing document for Friday’s panel, the FDA refers to one of the studies’ as “robust and exceptionally persuasive” while playing down on the failed contradictory study. Usually, the FDA is known to go into details of all facts instead of helping on the way. Unfortunately, the sceptical sections of the FDA’s statistical analysis highlighting series biases and inconsistencies in the data have been masked under a positive message.