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# Biogen Alzheimer’s BLA Filing Delayed
- URL: https://www.fdaweb.com/biogen-alzheimers-bla-filing-delayed/
- Published: 2020-04-22T12:00:00.000Z
- Updated: 2026-09-14T16:12:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146631

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](https://www.bizjournals.com/boston/news/2020/03/08/biogens-coronavirus-cases-rise-implicating-another.html?ref=fdaweb.com), according to [**Al Sandrock**](https://www.bizjournals.com/boston/search/results?q=Al%20Sandrock&ref=fdaweb.com), Biogen’s executive vice president. But the delay was largely attributed to what Vounatsos called a “complex and unprecedented dataset.”