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Home > New Research Update for Proposed ALS Drug Treatment — AMX0035

New Research Update for Proposed ALS Drug Treatment — AMX0035

by | Sep 15, 2021

We’re excited to share another milestone in the search for better drug treatments for ALS. Amylyx announced today that the company will soon submit a New Drug Application (NDA) for AMX0035 to the FDA. The ALS Association has been closely following the development of this treatment, even providing serious funding to propel its development.

Supporting the Development of a New Treatment

Many of these donations were received during the record-breaking ALS Ice Bucket Challenge in 2014. The ALS Association provided a grant of $750,000 for a clinical trial pilot in June 2016. The next month, a $1.46 million grant was provided to the Northeast ALS Consortium (NEALS) to fund the phase 2 CENTAUR clinical trial of AMX0035.

In September 2020, the concluded trial reports were released. They showed promise for this new drug. Those who received this AMX0035 experienced a significant slower progression of ALS than those who received the placebo. In terms of side effects, the drug presented itself as well-tolerated with a better benefit to risk balance. Read more about the CENTAUR phase 2 results here.

The Crucial Role of ALS Advocates

As soon as the results of phase 2 were released for AMX0035, ALS advocates jumped into action. In a team effort with I AM ALS, the ALS Association issued a petition. It urged the FDA and the drug company to make the treatment widely available as soon as possible. When the average lifespan is just 2 – 5 years after an ALS diagnosis, we can’t wait!

That’s just what ALS advocates communicated to the FDA just earlier this year in May. Eight ALS representatives from across the United States hosted a We Can’t Wait Action Meeting with the FDA. The meeting urged the FDA to act swiftly when it comes to approving new drug therapies for those living with ALS.

Our advocates play just as much as a role in the development and approval of new drugs as does the funding provided by generous supporters. With both these functions working in tandem, we can only hope for speedy approvals of future drug treatments.

What Comes Next?

Amylyx is currently conducting a third clinical trial (PHOENIX) of AMX0035; however, they can concurrently submit the NDA. It’s estimated that the drug company will submit this application sometime in the Fall 2021.

Following the application submission, the FDA will determine if they want to grant the new treatment approval. Or, contrarily, the FDA could require an additional study. This review process will take several months from the time of submission. In addition to the United States, Amylyx has also filed for approval of AMX0035 in Canada and the European Union.

In the meantime, the ALS Association plans to put pressure on the FDA to approve this treatment as soon as possible.

How ALS Patients Can Help

Once you’ve been diagnosed with ALS, it’s easy to feel like you just don’t have many options, but there are ways you can make a difference.

How You Can Help People With ALS

We all have a part to play in the fight against ALS! Your generous support funds critical research for better treatments and a cure for this disease. Here are a few ways you can help: