Health Canada conditionally approves Albrioza for the treatment of amyotrophic lateral sclerosis.
Amylyx Pharmaceuticals, Inc. announced that Health Canada has approved Albrioza (sodium phenylbutyrate and ursodoxicoltaurine), with conditions, for the treatment of amyotrophic lateral sclerosis (ALS).
Clinical data demonstrated a statistically significant and clinically meaningful benefit in functional outcomes for people with ALS taking Albrioza (also known as AMX 0035) compared to people taking placebo, either as a stand-alone therapy or when added to existing treatments for ALS. This decision marks the first marketing approval for Albrioza issued to Amylyx worldwide.
ALS is a relentlessly progressive and fatal neurodegenerative disorder caused by motor neuron death in the brain and spinal cord. Motor neuron loss in ALS leads to deteriorating muscle function, the inability to move and speak, respiratory paralysis, and eventually death. The vast majority of people with ALS ( greater than 90%) have sporadic disease, showing no clear family history. Approximately 3,000 Canadians are currently living with ALS, and the average life expectancy from symptom onset is two to five years. Approximately 1,000 people die from ALS in Canada every year, with a similar number of diagnoses annually.