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Statement about the FDA advisory committee on aducanumab

September 29, 2020 Company Statements

On September 29, 2020, it was published in the Federal Register that the U.S. Food and Drug Administration (FDA) will convene a virtual advisory committee meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to review data supporting the Biologics License Application (BLA) for aducanumab, an investigational product for Alzheimer’s disease. The advisory committee meeting is scheduled for November 6, 2020 and will be available for live streaming. 

The notice stated that the FDA intends to make the advisory committee meeting’s background materials and pre-recorded presentations available to the public no later than two business days before the meeting.  The notice also stated that, if the FDA is unable to post the background materials and/or pre-recorded presentations on its website prior to the advisory committee meeting, the background material and/or pre-recorded presentations will be made publicly available on the FDA’s website at the time of the advisory committee meeting.

The notice stated that the advisory committee meeting will include brief summaries of the pre-recorded presentations, discussion and oral presentations from the public. 

Safe Harbor

This statement includes forward-looking statements based on Biogen’s current expectations and beliefs that are subject to risks and uncertainties. Biogen’s actual results may differ materially.  Please consult the risk factors section of Biogen’s SEC filings. 

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