Biogen Reverses Abandoned Drug Trial, Now Looking for FDA Approval

Early this week, drugmaker Biogen made a surprising announcement of a plan to seek US regulatory approval of is new Alzheimer’s treatment.  The reveal comes after the latest data from two discontinued studies showed a couple patients that the drug did yield improvement to cognition, at least in high doses. 

With that announcement, as you might expect, Biogen’s shares skyrocketed 37 percent in premarket trade.  Fortunately for the company, this erased most of the losses they have already posted this year, which faltered out of two abandoned studies of the same drug.  

Biogen—and development partner Eisai Co Ltd—chose to end a pair of two late-stage trials of aducanumab based on what they called “futility analysis” of the data.  They concluded this revealed the trials would not succeed.  

Investors had grand expectations that this treatment would be Biogen’s next big blockbuster drug, so its failure received a lot of pressure from Wall Street for the company to spend more money on acquiring other products. This would be at a time when competitors have been digging deep, spending several billion dollars to do the very same thing. 

Fortunately for Biogen, more data became available after they had discontinued both studies, in March.  The larger dataset allowed for more analysis that managed to reveal one of the trials actually met its initial goal.  While the second study did not meets primary endpoint, there was enough data to reexamine the drug. 

Biogen chief executive Michel Vounatsos expresses excitement, noting, “With such a devastating disease that affects tens of millions worldwide, today’s announcement is truly heartening in the fright against Alzheimer’s. This is the result of groundbreaking research and is a testament to Biogen’s steadfast determination to follow the science and do the right thing for patients.”

Effectively, the discovery revealed that patients who had taken aducanumab eventually experienced significant benefits in terms of cognition, memory, orientation, and language skills. 

Vounatsos goes on to say, “We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of Alzheimer’s disease and the potential implication of these results for similar approaches targeting amyloid beta.”