News & Stories
On September 29th, the FDA approved AMX0035 (now known as Relyvrio) to treat people living with ALS. Relyvrio, while not a cure, is a victory for the entire ALS community and a significant step in the battle against ALS.
In the summer of 2014, millions of us took part in the ALS Ice Bucket Challenge. Celebrities, friends, and family members all dumped ice on their heads to help raise awareness and funds for ALS. Thanks to everyone who donated, one of the potential treatments that the ALS Association funded was AMX0035.
The ALS Association spent over $2 million helping fund the development and clinical trial of AMX0035. In September 2020, The ALS Association and I AM ALS submitted over 50,000 signatures to the FDA calling on the agency to approve AMX0035. In subsequent months, the Association and advocates held multiple meetings with FDA officials, including a public We Can’t Wait Action Meeting in May of 2021, so members of the ALS community could speak directly to FDA officials. Before AMX0035 will be made available, payers like Medicare and private insurance companies have to make determinations on whether and how they will cover the drug.