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!

While this recommendation does not guarantee FDA approval of AMX0035, it is a monumental step forward on the path to approval. Your voices and your stories are being heard. Thank you so much for sharing them.

Now for the next step: FDA approval! Let’s continue to do our part by encouraging the FDA to adhere to its own guidelines of regulatory flexibility for ALS. We can continue to share the science, which shows that AMX0035 is safe and effective, and can give those living with ALS precious time with their families and loved ones. 

And most of all, we can share our stories – of loved ones with ALS, of those we have lost as they waited for treatment, and of the next generation of people with ALS who could live to see a cure.

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.

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