ALS Canada Advocacy Update – April – June 2022

This blog series is a place for the ALS community to learn about and stay updated on ALS Canada’s advocacy efforts as well as relevant developments within government. Please note that because ALS Canada advocates federally and provincially within Ontario, these updates will primarily feature updates from the federal and Ontario provincial levels of government.

Therapeutics updates

ALBRIOZA (AMX0035)

• Health Canada approved ALBRIOZA (AMX0035) under a Notice of Compliance with Conditions (NOC/c). This means the drug is available and can be marketed in Canada under certain conditions.
• Health Canada’s approval is a positive step forward in the available treatment options for people living with ALS.
• Canada is also the first country to approve ALBRIOZA as a treatment for ALS – demonstrating the strength of the ALS community as an environment for innovative therapies.
• ALS Canada will continue to be involved in the CADTH Health Technology Assessment process and is actively working to support the pan-Canadian Pharmaceutical Alliance (pCPA) and the provincial drug programs to make informed and expedited reimbursement decisions by bringing forward the perspective and experiences of people affected by ALS.
• You can read more in the press release from Amylyx Pharmaceuticals Inc. (English only).

Oral edaravone

• Health Canada accepted Mitsubishi Tanabe Pharma Canada, Inc.’s filing of a Supplement to a New Drug Submission (SNDS) for an investigational oral formulation of edaravone.

• This step triggers a thorough regulatory review of the therapy, which could result in the drug being approved in Canada.
• We are also encouraged to learn that Health Canada has granted a Priority Review of the therapy, which expedites the review timeline to six months.
• We believe any new innovative ALS therapy should be granted priority review status – and we are hopeful this decision sets an important precedent for all future ALS therapies.
• You can read more in MTP-CA’s press release.

• On May 12, 2022, the FDA approved an oral formulation of edaravone, also known as oral edaravone, for adults living with ALS.
• Read more about the decision.

Masitinib

• Health Canada accepted AB Science’s New Drug Submission (NDS) for masitinib.
• This step triggers a thorough regulatory review of the therapy under the Notice of Compliance with Conditions (NOC/c) pathway.
• You can read more in AB Science’s press release.

Access to therapies

PMPRB regulations

• On April 14, 2022, Hon. Jean-Yves Duclos, the Minister of Health, announced that the government will not proceed with the amendments related to the new price regulatory factors.
• The government’s decision not to proceed with the amendments that could create barriers for companies to bring innovative medicines to Canada indicates that by working together to approach decision-makers, we can make our voices heard.
• We thank the ALS community for their advocacy efforts in creating this change.
• ALS Canada will continue to advocate for Canadians living with ALS to access proven ALS therapies in a timely, equitable, and affordable way.
• Read more about the change here.

Biogen clinical trial

• Based on data from a Phase 1 clinical trial, Biogen and Ionis Pharmaceuticals are discontinuing the development of BIIB078, their experimental treatment candidate for ALS caused by mutations in the C9ORF72 gene.
• Although the trial will not continue, the results will help inform future research.
• Read more about the decision here.

Cytokinetics ALS Patient Advocacy Partner Summit

• ALS Canada participated in the Cytokinetics ALS Patient Advocacy Partner Summit.
• The summit’s purpose was to engage patient groups in a discussion on public policy and community advocacy priorities.
• Coming together with our international partners gives us an opportunity to elevate our current advocacy initiatives and leverage collaborative opportunities to voice the Canadian ALS community’s concerns.
• Other attendees included the International Alliance of ALS/MND Associations, Muscular Dystrophy Association, the ALS Association, I AM ALS, ALS Therapy Development Institute, and other organizations from across the U.S.

Federal Updates

National Strategy for Drugs for Rare Disease roundtable

• Tammy Moore, CEO, ALS Canada, took part in a roundtable as part of Health Canada’s consultation on creating a National Strategy for Drugs for Rare Diseases, where she provided comments on the What We Heard from Canadians Report.
• The roundtable was an opportunity to reiterate the urgent need to change how drugs are made available in Canada and for Canadians living with ALS to access approved therapies in a timely way.
• Please read our consultation submission from March 2021 to learn more.

Provincial Updates

Government meetings

• Prior to the election, ALS Canada met with the Ontario Ministry of Health bureaucracy to discuss the solutions outlined in ALS Canada’s The Time is Now position paper and the need for Ontarians living with ALS to have expedited and equitable access to therapies.
• This meeting helped lay the foundation for future conversations surrounding ALS therapies and the need for Ontario to provide swift reimbursement.
• We will continue to engage with MPPs and other key decision-makers when the Legislative Assembly is in session.

2022 Ontario Elections

• On June 2, Ontarians voted to re-elect a Conservative majority government, with New Democrats remaining as the official opposition. Full election results can be found at Elections Ontario here.
• Key next steps for the provincial government include appointing a new Cabinet and swearing-in of MPPs at the Ontario Assembly.
• ALS Canada will continue to monitor these developments and begin engaging with new and returning MPPs in the coming weeks to discuss issues surrounding access to therapies in Ontario.
• You can view our election blog post, Knowing the issues that matter to Ontario’s ALS Community: 2022 Ontario Election, to learn more about parties’ commitments to address issues affecting the ALS community.

ALS Awareness Month

• On June 2, Lou Gehrig Day – ALS Caucus Co-Chairs MPs Francis Drouin and Marie-Hélène Gaudreau delivered Members Statements in the House of Commons in recognition of ALS Awareness Month.
• On June 3, MP Bryan May recognized ALS Awareness Month in the House of Commons and shared his support for Canadians living with ALS.
• Throughout June, Ontario-based MPs voiced their support of people affected by ALS through videos published on ALS Canada’s social media pages.

Note to readers: This blog is a source of information for the ALS community that provides an overview of advocacy efforts and current affairs for Canadians affected by ALS. While there are many topics presented in this blog update, they don’t represent ALS Canada’s official position on any particular issue, nor indicate a complete list of ALS Canada’s advocacy priorities. We’re also unable to share all details about certain engagements with industry stakeholders due to confidentiality reasons.

You can read past advocacy updates here.