On Thursday, 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.
You can read our letter here.
Our advocacy for swift approval for AMX0035 is just part of our efforts to bring greater speed and effectiveness to the agency. We continue to advocate for a series of policy actions to help the FDA accelerate development and delivery of effective therapies. Here is what else we are doing:
- In our appropriations request to Congress, we are asking for $50 million for the FDA to fund clinical research to benefit people with ALS. We also are supporting the Promising Pathways Act to give the FDA additional tools to enable earlier access to potential therapies.
- We continue to advocate for ACT for ALS legislation which supports access to experimental treatments and provides the FDA additional research capacity and public private partnerships to speed development and approval of new treatments.
- We are asking Congress to fund a study by the National Academies of Science and Medicine to help coordinate the entire ALS research agenda.
These efforts all support the FDA so it can do its part in bringing forward better treatments that extend and improve the lives of people with ALS. Now, we need the FDA to act quickly so that people living with ALS and their loved ones can benefit from new life-changing therapies.