Canada Approves Amylyx’s ALS Drug Albrioza
Health Canada has approved Amylyx Pharmaceuticals’ Albrioza (sodium phenylbutyrate and ursodoxicoltaurine) for treatment of patients with the rare progressive nervous system disease amyotrophic lateral sclerosis (ALS) disease, also known as Lou Gehrig's disease.
The conditional approval requires the company to submit data from an ongoing phase 3 clinical trial and from additional studies to support a full approval of the oral drug.
The conditional approval was based on results of a phase 2 study in 137 participants. Patients who received Albrioza demonstrated a 2.32-point higher average score on the ALS Functional Rating Scale compared with those given a placebo.
In March, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted not to recommend the drug for FDA approval. The agency is still reviewing the company’s application and has a user fee decision date of Sept. 29.
About ALBRIOZA™
ALBRIOZA™ (sodium phenylbutyrate and taurursodiol) is an oral fixed-dose medication approved with conditions to treat amyotrophic lateral sclerosis (ALS) in Canada. The combination of sodium phenylbutyrate and taurursodiol may reduce neuronal cell death, hypothesized to occur by simultaneously mitigating endoplasmic reticulum (ER) stress and mitochondrial dysfunction. ALBRIOZA is being explored for the potential treatment of other neurodegenerative diseases.
About Amylyx Pharmaceuticals
Amylyx Pharmaceuticals, Inc. is committed to supporting and creating more moments for the neurodegenerative community through the discovery and development of innovative new treatments. Amylyx is headquartered in Cambridge, Massachusetts and has operations in Canada and EMEA. For more information, visit amylyx.com and follow us on LinkedIn and Twitter. For investors please visit investors.amylyx.com.
June 14, 2022
