On Monday, April 25, an FDA Advisory Committee will review eteplirsen for potential approval and use within our Duchenne community.
The Duchenne community is joining forces in a show of strength to demonstrate to the FDA our community’s support for our robust therapeutic pipeline. Over 850 Duchenne community members are scheduled to attend the Advisory Committee meeting to show our community’s support of eteplirsen.
We are excited that people with Duchenne and their families will have the opportunity to share their experiences with regulators and we remain hopeful that the FDA will render the decision we all so desperately want: APPROVAL.
While many of you may be attending in person or even participating, we know that those of you unable to attend are curious as to how the process will unfold throughout the day. See below for information on how you can follow along from home.
Watch a live stream of the Ad Comm
The Center for Drug Evaluation and Research (CDER) plans to provide a free of charge, live webcast of the meeting. Please note that the webcast will not display until the meeting begins at approximately 8:00 a.m. EST on April 25, 2016. While CDER is making a webcast available to the public for this meeting, there may be instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.
The meeting webcast can be accessed at the following web addresses:
For more information regarding the live webcast, view the FDA's official notice.
A draft agenda for the meeting can also be accessed on the FDA website:
Follow PPMD's updates on Twitter
Make sure to follow @ParentProjectMD on Twitter, using the hashtag #MakeDuchenneHistory. The PPMD team will be providing regular live updates.
For more information about the FDA Ad Comms, please visit the links and resources that we at PPMD have compiled over the past few months with the assistance of our community members, regulatory advisors, and federal agency partners: