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Amylyx Updates

| Theresa Garner (She/Her)


Amylyx Plans to Submit NDA

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Media Contact: Theresa Garner, [email protected]

I AM ALS celebrates Amylyx Pharmaceuticals’ plan to submit a new drug application (NDA) to the FDA for approval of its AMX0035 treatment in the coming months. The move follows months of sustained advocacy, including more than 50,000 people in the ALS advocacy community signing a petition to make AMX0035 available to people with ALS.

On October 18, 2020, in response to the New England Journal of Medicine publication of encouraging clinical trial results showing that Amylyx Pharmaceuticals’ AMX0035 brought statistically significant benefit to people living with ALS, The ALS Association and I AM ALS immediately called on the drug company and the FDA to make the treatment widely available as soon as possible. Data from the trial (known as CENTAUR), indicates the drug met its pre-specified, primary outcome and represents a significant development for the ALS community.


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