From Early 2020 To Q3: Biogen Shifts Aducanumab Filing Expectations Again

The company remains confident in US FDA approval for the first disease-modifying Alzheimer’s drug based on current data, but Biogen needs more time to complete the BLA filing.

Mobile Electronic Traffic Sign stating “expect Delays” taken at sunset with traffic blurred driving past the sign and traffic cones — Biogen will file its aducanumab BLA in Q3 versus prior guidance of early 2020 • Source: Shutterstock

Biogen still believes that aducanumab can win US Food and Drug Administration approval as the first disease-modifying treatment for Alzheimer’s disease, but external confidence in the company’s ability to achieve that goal in a timely manner was shaken on 22 April. That's when Biogen revealed in its first quarter earnings report that it does not expect to complete the biologic license application (BLA) for aducanumab until the third quarter of this year.

The company has said since October that it would file the BLA in early 2020, although Biogen’s guidance in January...