Barbara Binzak Blumenfeld, shareholder in the firm's Life Sciences practice, comments on the noteworthy reversal of Biogen's trial of an Alzheimer's disease drug and seeking FDA approval in S&P Global Market Intelligence's article "Experts Map Out Path to Approval After Biogen's Unusual Alzheimer's Reversal."
Barbara Binzak Blumenfeld, a regulatory expert and partner at Buchanan Ingersoll & Rooney, told S&P Global Market Intelligence in an interview that, while the turnaround is remarkable, the futility study that originally led Biogen and Eisai to abandon the trial was viable at the time.
"There was a decision to not pursue the product any further because it looked prospectively as if the drug was not going to have the intended effects," said Binzak Blumenfeld, who also serves as a U.S. FDA regulatory expert. "There comes a point that if the drug is not going to work, you have to make a decision whether to continue the study or not."
Binzak Blumenfeld said that the medical community was disappointed in aducanumab's initial failure, and the turnaround is marked by "such elation now." She could not point to any historical precedent for such a dramatic reversal.
Biogen met at least twice with FDA officials in June and October to discuss clinical results before submitting for approval.
"My speculation is that the company would not have made this major announcement that it's going to file if it didn't feel that it had some positive feedback from the FDA," Binzak Blumenfeld said. "All of that being said, what the FDA will do in the long run will certainly depend on them taking a full look at all of the data that they do have."
The aducanumab reversal is an anomaly in Binzak Blumenfeld's mind, and is unlikely to spur many companies to re-evaluate high profile failures.
"This in my mind presents a conundrum: There are times when a company wants to employ this mechanism to decide, is it worth it not only to patients, but simply from a company point of view, to pursue this?" Binzak Blumenfeld said. "I don't think it means futility analyses are going to go by the wayside, but I do think it may impact how statisticians, drug developers and drug companies look at data before they have the full clinical picture."