The U.S. Food and Drug Administration (FDA) will hold a second public advisory committee meeting on September 7, 2022 to discuss new data about the safety and efficacy of AMX0035, a new treatment for ALS from Amylyx Pharmaceuticals. Following this meeting, the advisory committee will present a non-binding recommendation to the FDA. The FDA will make a determination on the AMX0035 New Drug Application by September 29.
The Les Turner ALS Foundation supports the approval of AMX0035, which studies have shown to be the first ALS therapeutic that demonstrates both a statistically significant survival and functional benefit for people with ALS.
Members of the ALS community are invited to submit written comments to the FDA. You can type your comments directly into the comment box or upload a file such as a PDF or a Word document. Comments received by August 23 will be presented for consideration to the advisory committee.
We encourage you to share your personal thoughts and perspective on AMX0035 and the urgent need for new ALS treatments. You may wish to include any of the following topics:
- How ALS has affected you and your family
- New analysis of data shows that AMX0035 can extend survival by 10 months. What would that mean to you and your family?
- Data also shows that AMX0035 can slow decline in function by as much as 25%. How would that affect the time you share with a loved one?
- AMX0035 has been shown to be safe for people living with ALS.
- This is a huge unmet medical need, and the FDA has the regulatory authority and flexibility – and sufficient data – to approve this therapy.
Your voice and experience can help members of the advisory panel understand the priorities of the ALS community. We have no time to waste.
