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.
Later this month, the ALS Association will host a virtual session focused on the urgent need for timely access to new therapies. Leaders from the U.S. Food and Drug Administration (FDA) and industry companies will listen to people living with ALS speak directly about their expectations for their experiences with the disease and how important it is to have timely access to therapies that have the potential to provide incremental benefit in improving how people feel, function and live.
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.
Ionis Pharmaceuticals announces pivotal patient trial of antisense therapy following aggressive joint research effort led by the nonprofits The ALS Association and Project ALS.
The ALS Association is excited to announce $2.5 million in grants to help develop promising new treatments for people living with ALS.
The grants are supported by the Association’s Lawrence and Isabel Barnett Drug Development Program, which supports drug discovery research in both academia and industry to develop new drug therapies and test them in a preclinical setting while moving those therapies closer to clinical use.
Collaboration is a cornerstone of The ALS Association’s global research program. That’s why The Association hosts an annual ALS Drug Company Working Group that brings together representatives from pharmaceutical companies and academia to discuss how to move ALS research and therapy development forward.