Biogen Alzheimer’s BLA Filing Delayed

Biogen says it is delaying a BLA for aducanumab, an anti-amyloid beta antibody candidate for the potential treatment of Alzheimer’s disease that it is developing in collaboration with Eisai Co. The company has a rolling BLA planned and has started to submit modules of the filing. Biogen has met with the agency in Type C meetings and is preparing for a pre-BLA meeting, currently scheduled for the summer and a final submission is expected in the third quarter, it says. Previously, the company said the BLA would be submitted in early 2020.

Biogen executives said that Covid-19 is causing some of the delay. A few members of the aducanumab application team were among the 100-plus employees who contracted Covid-19, according to Al Sandrock, Biogen’s executive vice president. But the delay was largely attributed to what Vounatsos called a “complex and unprecedented dataset.”