Biogen delays approval submission of closely watched Alzheimer’s drug

April 22, 2020

Citing challenges with the spread of COVID-19 among its staff along with data issues, Biogen has decided to hold off on submitting an application for the approval of its Alzheimer’s drug.

Biogen originally abandoned its quest to seek approval for its experimental treatment, aducanumab, last March, after it failed to show efficacy in two late-stage trials. Then, the company made a surprise announcement in October that it had reanalyzed the data and found that some patients had benefitted from the drug at higher doses. Biogen then planned to submit its application early this year.

Then the coronavirus pandemic hit not just the world, but Biogen specifically, which held a meeting in early March that became a “super spreader” event and was linked to nearly 100 cases. Although all of its employees with the coronavirus have reportedly recovered, Biogen said that has been difficult for its staff to work while dealing with the illness.

The company said that it also needs more time to prepare its data. 

Biogen now hopes to submit its application by the third quarter of this year, but news of the delay sent shares for the company plummeting by 11 percent Wednesday morning. 

Read the Reuters report.