On September 29, 2022, the US Food and Drug Administration (FDA) approved AMX0035 (sodium phenylbutyrate and ursodoxiltaurine) for the treatment of adults with amyotrophic lateral sclerosis (ALS) under the brand name RELYVRIO. Approval is currently being applied for in the European Union (EU), and a final statement from the European Medicines Agency (EMA) is expected in the first half of 2023.

Unfortunately, the preparation will not be available in Europe until then. The only access to AMX0035 in Europe is participation in the PHOENIX drug study, in which our special consultation hours also take part. For more information about the study, including eligibility criteria and participating sites, visit https://www.amylyxalstrial.com.