02 Oct 2020

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will meet virtually on November 6, 2020, to discuss Biogen/Eisai’s biologics license application for aducanumab. This follows the agency’s decision last summer to grant this application priority review (Aug 2020 news). 

As is typical of FDA advisory committee meetings, the administration will share background material and prerecorded presentations online beforehand, in this case by November 4. Interested parties can submit comments, data, or presentations in writing or online. Submissions received by October 23 will be forwarded to the committee. Those received after that date but by end of day November 5, U.S. Eastern time, will also be considered by the FDA. Confidential comments should only be made in writing.

To be held from 10 a.m. to 4 p.m. EST, the advisory committee meeting will be broadcast live by webcast. Limited oral comments from interested parties will be allowed. Anyone planning to present must submit a notice to that effect by October 15, outlining the gist of their argument, authors, and approximate time needed. Because only one hour is allotted for public oral arguments, the FDA may select oral presentation by lottery.

The link for the webcast will made available by November 4. It will appear, along with links to the relevant background information, on the FDA announcement page.—Tom Fagan