The FDA’s decision to approve Amylyx Pharmaceuticals’ therapeutic compound AMX0035 for treatment of ALS was fully justified by the data and the science. Clinicians, researchers, advocacy groups, and people living with ALS spoke in overwhelming numbers in favor of approval. The reasons are clear: AMX0035, now known as RELYVRIO™, addresses an urgent and unmet medical need. It is safe and effective for treatment of ALS.
Trials have shown that this treatment can extend survival by 10 to 18 months and slow decline in function by as much as 25%. That is an extraordinary clinical benefit. For the community we serve, it is more time with the people they love, sharing the moments that make life worth living. It is a gift beyond measure.
We’re glad that RELYVRIO™ will soon be available to people living with ALS in the United States, and we applaud the FDA for meeting the urgency of this moment. This is more than a step forward – it is momentum, and it must continue. We have no time to waste.