Media Contact: Theresa Garner, Theresa@iamals.org
FDA Announces Advisory Committee (AdCom) Meeting for AMX0035
AMX0035 (aka PB/TURSO) is an investigational drug under review by the FDA for treatment of ALS. As part of the review, the FDA recently announced an Advisory Committee (AdCom) meeting, in which a group of scientific advisors will convene to review data and testimony from key stakeholders. These scientific advisors are NOT part of the FDA but are appointed based on their expertise in a particular subject area – in this case, the Central and Peripheral Nervous System. Members of the AdCom will then make a recommendation to the FDA regarding approval of AMX0035, which the FDA will take into consideration when determining if the drug can become commercially available. The AdCom meeting will be held on March 30, 2022.
- I AM ALS CEO Laura Dalle Pazze’s testimony to the FDA Advisory Committee
- I AM ALS statement for docket FDA-2018-N-0410 regarding the review of Amylyx Pharmaceuticals’ AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS)
- What you need to know about the upcoming Advisory Committee (AdCom) meeting for AMX0035 and how you can help
- Watch a Community Conversation hosted by I AM ALS
Amylyx Announces Plan to Submit AMX0035 to the FDA for Approval
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.
Amylyx Releases Trial Data on AMX0035
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.