The ALS community has the opportunity to encourage The Food and Drug Administration (FDA) to approve Amylyx Pharmaceutical’s new drug application for AMX0035.
The ALS Association has formally objected to the use of controversial measures to evaluate ALS drugs that can make it harder to find effective new ALS treatments and get them to the ALS community as quickly as possible. These measures have been identified by the National Council on Disability as being inherently discriminatory against people with disabilities.
We asked the FDA to treat the approval review process of AMX0035 with urgency. Specifically, we sent a letter to FDA asking the agency to conduct a Priority Review of Amylyx’s New Drug Application (NDA) for AMX0035 and then approve it. The Priority Review is an expedited review process, as opposed to the Standard Review process, which can take upwards of a year after the agency accepts submission of the NDA.
Amylyx recently filed a New Drug Application for AMX0035, a promising new drug that has proven safe and effective at slowing progression of ALS and extending the life of people living with the disease. The ALS Association has called on the FDA to approve the application with urgency.
After Amylyx’s announced that it intends to file a new drug application for AMX0035, The ALS Association immediately called on the U.S. Food and Drug Administration to approve the treatment for all people with ALS as soon as possible. Connecting ALS talked to the team at Amylyx to learn about the path ahead for access to AMX0035.
There is a lot to do, and this grounded focus of making ALS livable helps us hold everyone—ourselves, the FDA, and the research community—accountable to real impacts on real people with ALS and the time it takes to deliver those impacts. This week has been a big step forward for the ALS community, and we will continue urgently working to keep the momentum going.
Following Amylyx’s announcement that it intends to submit a New Drug Application (NDA) for AMX0035, The ALS Association today urges the Food and Drug Administration to approve the treatment for all people with ALS as soon as possible.
Following the lack of action by the FDA to expedite approval of AMX0035, an experimental treatment for ALS, The ALS Association today called on the agency to follow its own guidance and move with the urgency of its Canadian and European Union counterparts. Health Canada and the European Medicines Agency (EMA) are working with Amylyx, the company that makes AMX0035, to move the treatment toward approval.
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More than 43,000 people signed The ALS Association’s petition, launched September 3 with I Am ALS, to call on the FDA and Amylyx Pharmaceuticals to work together to speed up the process of getting AMX0035 available for people living with ALS as quickly as possible.