TORONTO, August 18, 2023 /CNW/ - Amylyx Pharmaceuticals Canada announced today the Company has entered a Product Listing Agreement with the province of Newfoundland and Labrador for the public reimbursement of ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine), effective August 16, 2023. The medication will be reimbursed for its use in treating amyotrophic lateral sclerosis (ALS) through the Newfoundland and Labrador Prescription Drug Program. In the CENTAUR clinical trial, ALBRIOZA demonstrated a significant reduction in disease progression and functional decline among individuals diagnosed with ALS.i This outcome has the promising potential to afford individuals with ALS with longer periods of functional independence and enhanced quality of life. 

“We are so pleased that the province of Newfoundland and Labrador has taken this step to support people impacted by ALS,” said Cheryl Power, Executive Director of the ALS Society of Newfoundland and Labrador. “People living with this rapidly progressive disease, along with their families, understand all too well that time is precious. Access to newly approved treatments makes all the difference to improved quality of life and more time to spend with the people who matter most to them.”

Amylyx continues to work with additional provincial, territorial, and federal drug plans in an effort to have ALBRIOZA listed on public formularies across the country.  

“We greatly appreciate the commitment shown by the Newfoundland and Labrador government to their residents living with ALS by making ALBRIOZA publicly accessible. Those who rely on public insurance coverage will be able to access this treatment in a timely manner, which is critical when facing such a relentlessly progressive disease,” said Chris Aiello, General Manager and Head of Canada at Amylyx. “We are continuing conversations with other Canadian drug plans to help ensure Canadians in every jurisdiction have equitable access to this treatment.”  

As the disease advances, individuals living with ALS experience a reduction in physical functions. This will significantly impact their ability to perform activities like feeding and dressing themselves, as well as speaking with and hugging loved ones. The disease ultimately leads to the loss of essential functions like swallowing and breathing. The median life expectancy is just two years following diagnosis.

“I am pleased to know that ALBRIOZA has been listed on the provincial drug plan,” said Dr. Alan Goodridge, Neurologist with NL Health Sciences based in St. John’s and Professor of Medicine (Neurology) at Memorial University. “This is an important step forward providing an additional tool to help in the care management of people living with this challenging neurological disorder.”

About ALS 

ALS is a relentlessly progressive and fatal neurodegenerative disorder caused by motor neuron death in the brain and spinal cord with a median life expectancy of two years from diagnosis.ii Motor neuron loss in ALS leads to deteriorating muscle function, the inability to move and speak, respiratory paralysis and eventually, death.  

About ALBRIOZA™ 

ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine), previously known as AMX0035, is an oral fixed-dose medication approved with conditions to treat amyotrophic lateral sclerosis (ALS) in Canada. It is approved to treat ALS in adults in the U.S. as RELYVRIO®. AMX0035 is being explored for the potential treatment of other neurodegenerative diseases. The formulation of RELYVRIO, ALBRIOZA, and AMX0035 are identical. 

About Amylyx Pharmaceuticals 

Amylyx Pharmaceuticals, Inc. is committed to supporting and creating more moments for the neurodegenerative disease 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.ca and follow us on LinkedIn and Twitter.  

For media inquiries, please contact the Amylyx Media Team at +1 (857) 799-7274 or amylyxmediateam@amylyx.com.  
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i Long-term survival of participants in the CENTAUR trial of sodium phenylbutyrate-taurursodiol in amyotrophic lateral sclerosis - PubMed (nih.gov)

ii Survival and epidemiology of amyotrophic lateral sclerosis (ALS) cases in the Chicago and Detroit metropolitan cohort: incident cases 2009–2011 and survival through 2018