Amylyx Pharmaceuticals (AMLX) Launches ALBRIOZA in Canada for Treatment of ALS

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Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine) is now commercially available in Canada for people living with amyotrophic lateral sclerosis (ALS). ALBRIOZA ( 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. In a clinical trial, ALBRIOZA significantly slowed disease progression and loss of functional decline in people living with ALS.

“We have remained steadfast in our commitment to ensure ALBRIOZA would be available in Canada as quickly as possible following Health Canada’s decision to approve ALBRIOZA, with conditions, in June,” said Margaret Olinger, Chief Commercial Officer at Amylyx. “We are pleased that starting this week, we are ready to fill prescriptions for ALBRIOZA.”

Amylyx filed reimbursement submissions to the Canadian Agency for Drugs and Technologies (CADTH) and Institut national d’excellence en santé et en services sociaux (INESSS) in Quebec as part of an aligned Health Technology Assessments (HTA) review with Health Canada in parallel with the regulatory process to reduce the timelines required for patient access. The Company is continuing to work with the pan-Canadian Pharmaceutical Alliance, Federal, Provincial, and Territorial public drug plans, and private insurers to expeditiously achieve listing and reimbursement, so that eligible Canadians living with ALS can have access to ALBRIOZA as quickly and efficiently as possible.

“In Canada, prescription drugs undergo a thorough and often long review and approval process across regulatory, HTA, pricing negotiations, and formulary listing with public drug plans. In addition, private insurers have their own review and listing processes,” said Chris Aiello, General Manager and Head of Canada at Amylyx. “We continue to work diligently to navigate reimbursement processes to pursue broad and equitable access to ALBRIOZA across all provinces in Canada.”

“Market availability is an important milestone in the available treatment options for people living with ALS,” said Tammy Moore, CEO of the ALS Society of Canada. “As we look forward, we do not want to see coverage decisions become a barrier to access , and we urge the decision-makers throughout the drug access and reimbursement process to work expeditiously to provide equitable access for all eligible Canadians living with ALS who are in desperate need.”

As part of Amylyx’ continued commitment to the ALS community, through the Amylyx Care Team (ACT) Support Program, Amylyx provides insurance navigation, treatment coordination and educational support for people living with ALS who have been prescribed ALBRIOZA in Canada and their caregivers. Eligibility and enrollment into the ACT Support Program can be discussed with prescribing health care professionals.

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