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Amylyx Pharmaceuticals Announces Health Canada Approval of ALBRIOZA™ for the Treatment of ALS
Health Canada decision signifies the first global regulatory approval for Amylyx and the first new therapy for ALS approved in Canada since 2018 ALBRIOZA
About this update from Amylyx Pharmaceuticals, Inc.
[{"type":"text","content":"\n\nHealth Canada decision signifies the first global regulatory approval for Amylyx and the first new therapy for ALS approved in Canada since 2018\n\n\n\nALBRIOZA (also known as AMX0035) is an oral fixed-dose combination therapy that may reduce neuronal cell death as a stand-alone therapy or when added to existing treatments\n\n\n\nIn a clinical trial, ALBRIOZA significantly slowed disease progression and loss of functional decline in people living with ALS\n\n\n\nDetailed data from the CENTAUR clinical trial were published in the New England Journal of Medicine, Muscle & Nerve, and the Journal of Neurology, Neurosurgery and Psychiatry\n\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAmylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today 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 AMX0035) 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.\n\n“For nearly a decade, we have been committed to creating more meaningful moments for people living with ALS and their families. We are excited with Health Canada’s decision to approve ALBRIOZA with conditions. ALBRIOZA is a therapy that demonstrated in our CENTAUR trial a statistically significant and clinically meaningful impact on function, alone or in addition to existing ALS therapies. We are grateful to the people who participated in our clinical trials, their families, the researchers, and the ALS community for helping to make this milestone happen,” said Justin Klee and Joshua Cohen, Co-CEOs and Co-Founders of Amylyx.\n\nALS 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 (>90%) have sporadic disease, showing no clear family history. Approximately 3,000 Canadians are current...