• Ontario lists ALBRIOZA on its drug benefit formulary, becoming the first province to publicly reimburse ALBRIOZA, effective June 22, 2023

Toronto, June 28, 2023 /CNW/ - Amylyx Pharmaceuticals Canada announced today that the Company has entered into a Product Listing Agreement with Ontario for the public reimbursement of ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine) through the Ontario Drug Benefit Program effective June 22, 2023. ALBRIOZA significantly slowed disease progression and loss of functional decline in people living with amyotrophic lateral sclerosis (ALS), potentially giving them more time with functional independence, in a clinical trial.i The decision to list ALBRIOZA on Ontario's Exceptional Access Program swiftly followed the June 15, 2023 announcement that Amylyx completed the negotiation process and entered into a Letter of Intent (LOI) with the pan-Canadian Pharmaceutical Alliance (pCPA).

“We congratulate the Ontario government on its decision to reimburse this treatment in such a timely manner following pCPA negotiations,” said Tammy Moore, CEO of the ALS Society of Canada. “Because of the speed at which this fatal disease progresses, with a life expectancy of two to three years following diagnosis, timely access to this treatment is crucial. It is vital that all other jurisdictions move forward with similar urgency in making this treatment accessible. Canadians living with this devastating disease should have access regardless of where they live.”

Amylyx is continuing to work with the other provincial, territorial, and federal drug plans to have ALBRIOZA listed on public formularies across the country. 

“We are thrilled Ontarians with public insurance who are living with ALS will now have access to ALBRIOZA, and we are grateful for the collaboration of the Ontario government to make timely access possible,” said Chris Aiello, General Manager and Head of Canada at Amylyx. “This is an important milestone, however our work is by no means done. We are dedicated to ensuring that all who rely on public coverage in Canada can also access the treatment as soon as possible. People living with ALS are on a different clock, and thus we are moving urgently to obtain timely, equitable access for all eligible Canadians.”

As the disease progresses, people living with ALS will lose their mobility, their ability to feed and clothe themselves, speak with and hug their loved ones, and eventually they’ll lose the ability to swallow and even breathe.   

“Given the rapid decline in function experienced by people living with ALS, timely access to treatment that may slow the progression of the disease and preserve function for longer is critical,” said Dr. Christen Shoesmith, medical director of the ALS clinic at the London Health Sciences Centre and current Canadian ALS Research Network (CALS) chair. “I look forward to news of ALBRIOZA’s listing on other public drug plan formularies for eligible Canadians coast-to-coast.”

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 inquires, 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