Guide to Submitting Written Testimony to the FDA about AMX0035
On September 7, 2022, the FDA will host their second public advisory committee meeting (AdCom) about AMX0035. At the AdCom, a panel will review and evaluate new data provided by Amylyx about AMX0035’s safety and efficacy and provide input that will help inform the FDA’s ultimate decision about AMX0035’s New Drug Application. The deadline for the approval decision (the “PDUFA” date) is now set for September 29, 2022.
The FDA invites people to submit written comments about AMX0035 to the AdCom panel for their review prior to the September 7th meeting. People must submit their comments by 11:59pm ET on August 23 for them to be provided to the panel for consideration.
This is your time to make the case for AMX0035’s approval. Here are some tips to help make your comments impactful:
- Explain how ALS has affected you and your loved ones.
- New analyses indicate AMX0035 may extend survival for people living with ALS by up to 10-18 months. What would 10-18 more months mean to you and your loved ones?
- Data also shows that AMX0035 can slow decline in function by as much as 25%. What would having more use of your muscles for a longer period of time mean for you and your loved ones?
- Data shows AMX0035 is safe for people living with ALS.
- The unmet medical need for people living with ALS is critical. They need therapies that work. The data shows that AMX0035 is safe and effective, and the FDA has tools to act with urgency and flexibility for ALS.
For additional information, see the letter that I AM ALS, The ALS Association, Les Turner ALS Foundation, Answer ALS Foundation, and Team Gleason released earlier this summer calling on FDA to act urgently upon the AMX0035 drug application here.
Your perspective on the data and expertise in how ALS impacts people are invaluable. Please consider submitting written comments here.
We will find cures for ALS. The only question is when. That answer depends on you.
Stay informed on I AM ALS’ progress and what you can do to help us make hope real.
I AM ALS statement regarding 7 – 2 vote in favor of AMX0035 approval
On September 7, 2022, the Peripheral and Central Nervous System Drugs Advisory Committee (AdCom) met for the second time to discuss the New Drug Application (NDA) for AMX0035. After hearing from clinicians, scientists, field experts, and people living with ALS, the committee voted 7 - 2 in favor of approval!