Albrioza, also known as AMX0035, has been approved by Health Canada subject to conditions, including being dependent on the safety and efficacy data from the ongoing Amylyx Pharma Phase 3 PHOENIX trial.
The previous phase 2/3 clinical trial called CENTAUR achieved its primary endpoint of slowing decline in function as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) relative to placebo. AMX0035 is the first investigational therapy to demonstrate statistically significant benefit on this prespecified primary outcome in people with ALS since edaravone.
This decision is an advancement in available treatment options for people with MND. If results from the larger phase 3 PHOENIX trial are positive, hopefully more countries will follow Canada’s lead on granting approval . Click here to read more.
