ALS Action Canada urges the Government of Canada and Health Canada to swiftly approve new ALS drug therapeutic AMX0035

Published May 5, 2021

The Right Honourable Justin Trudeau, P.C., M.P.
Prime Minister of Canada
Office of the Prime Minister
80 Wellington Street
Ottawa, ON K1A 0A2

The Honourable Patty Hajdu, P.C., M.P.
Minister of Health
House of Commons
Ottawa, ON K1A 0A6

May 5, 2021

Dear Mr. Trudeau and Ms. Hajdu,

We are writing on behalf ALS Action Canada,[1] a patient-led advocacy organization formed in 2020. Like I AM ALS[2] in the United States, we are part of a growing, global, patient-led movement to finally #EndALS.

Our organization exists to advocate for:

  • Rapid approvals of and swift, pan-Canadian access to promising new therapies for ALS, including Amylyx Pharmaceuticals Ltd.’s AMX0035[3], which will soon be submitted to Health Canada;
  • Increased access by people living with ALS to more, and better-designed clinical trials across Canada, including platform trials (which requires the establishment of three more top-tier ALS clinics in this country, beyond Sunnybrook Health Sciences Centre and the Montreal Neurological Institute-Hospital);
  • Increased Government of Canada and provincial funding for ALS research in Canada.

On March 9, 2021, Cambridge, MA-based Amylyx Pharmaceuticals Ltd. announced its plans to submit a New Drug Submission (NDS) for AMX0035 for the treatment of ALS with Health Canada in the first half of 2021.

This decision is based on positive clinical data from Amylyx’s trial[1], feedback from Health Canada, and the potential of access through a special access program with collaboration from the Canadian ALS Research Network. AMX0035 combines two already approved medicines, offers ample safety data, and is the first drug therapy proven to substantially slow the progression of ALS.

We respectfully request the following:

  1. That Health Canada swiftly review and approve AMX0035 upon its submission.
  2. That  the Government of Canada move forward on the bi-partisan petition e-2971[5], tabled in Parliament by Heather McPherson, M.P. (Edmonton Strathcona) on March 11, 2021, which gained over 25,000 signatures, that called on the Minister of Health to create a pilot project to reduce the delay in obtaining access to innovative, Health Canada-approved ALS treatments to maximum 3 to 6 months, Canada-wide.
  3. That, beginning with AMX0035 and going forward, the Government of Canada better coordinate efforts with provincial and other stakeholders (including the Patent Medicines Prices Review Board, the Canadian Agency for Drugs and Technologies in Health, and the pan-Canadian Pharmaceutical Alliance) to position Canada as a world leader in clinical research, regulatory review, health technology assessment, and drug funding decisions that provide access to promising therapies that treat ALS.

In the case of the PMPRB, the changes due to come into effect on July 1, 2021 are a major obstacle for innovative pharmaceutical companies that would otherwise prioritize Canada as a destination for basic, translational, and applied research and, most importantly, commercialization of new ALS therapeutics.

  1. That Health Canada enter into an agreement with the international peers to use the model of Project Orbis[1], an initiative of Health Canada and the US FDA Oncology Centre of Excellence, which provides a framework for the concurrent submission and review of oncology products among international regulators, to share resources and approve new drug therapies for ALS in a faster, harmonized manner.

Canadians have seen COVID-19 vaccines approved by Health Canada within a couple of weeks of submission, and made accessible Canada-wide almost immediately. The Government of Canada can work quickly, and with the provinces, when there is a will to do so and an understanding of the urgency.

Canadians living with ALS and their families have no time to waste. Most people diagnosed with ALS live no more than five years after diagnosis. The lives of people with ALS have no less value than those facing COVID-19 or cancer. New treatments like AMX0035 (and Toferesen[1], by Biogen Pharmaceuticals) represent the best and only hope to date for people living with ALS.

We look forward to meeting with you at your earliest convenience to discuss the above recommendations, and learn more about your plans to improve the lives of Canadians with ALS.

Yours sincerely,

Captain Deane Gorsline, CD, BEng, PMP, rmc
Royal Canadian Engineers
ALS Action Canada Executive Committee
Diagnosed with ALS 2018, age 29
159 McCurdy Drive
Kanata, ON K2L 2Z7
250 991 2626

Greg Gowe, BA, MA, LLB
Former Senior Counsel, TELUS
Director, ALS Action Canada
Diagnosed with ALS 2019, age 48
479 Saville Crescent
North Vancouver, BC V7N 3A9
604 341 9893
goweg@yahoo.ca
alsactioncanada@gmail.com

Dr. Rheanna Robinson, PhD
Assistant Professor, UNBC
ALS Action Canada Executive Committee
Late brother diagnosed with ALS 2020, Age 42
7564 Hough Place
Prince George, BC V2N 0A5
250 613 9787
Rheanna.Robinson@gmail.com
alsactioncanada@gmail.com

Mark Kirton
RE/MAX Aboutowne Realty, former NHL player
ALS Action Canada Executive Committee
Diagnosed with ALS 2018, age 60
1131 Nottinghill Gate, Suite 207
Oakville, ON L6M 1K5
905 483 0053
mark@markkirton.com
alsactioncanada@gmail.com

Diana Rogers
ALS Action Executive Committee
Diagnosed with ALS 2017, Age 47
Toronto, ON
416 559 7502
dianarogers100@gmail.com
alsactioncanada@gmail.com

Petty Officer 2nd Class William Duff, CD
Royal Canadian Navy
ALS Action Canada Executive Committee
Diagnosed with ALS 2016, age 29
Halifax, NS
250 415 7619
williamhduff@gmail.com
alsactioncanada@gmail.com

Shelley A. Hines
ALS Action Canada Member
Daughter diagnosed with ALS in 2018, age 23
108 Flagstone Drive
Dartmouth, NS B2V 1Z8
902 497 7693
hinesshelley6@gmail.com
alsactioncanada@gmail.com

Cali Orsulak, BscPharm,  BCPS, CDE
Pharmacist, SharedHealth Manitoba
ALS Action Canada Executive Committee
Advocate and caregiver to partner diagnosed with ALS 2019, age 43
182 Rue Messager
Winnipeg, MN R2H0A1
204 770 9312
calidawn@hotmail.ca
alsactioncanada@gmail.com

Barbara Gorsline B.S.R,  MCPA, CGIMS, RCAMT
Registered Physiotherapist
ALS Action Canada Executive Committee
Son diagnosed with ALS 2018, age 29
1540 Dragon Lake Road
Quesnel, BC V2J 6G3
250 991 2626
bgorslin@gmail.com
alsactioncanada@gmail.com

Rick Wilson, CPA CMA
Executive Vice President, BidGroup
Director, ALS Action Canada
Person living with ALS
16308 27A Avenue
Surrey, BC V3Z 6R8
604 612 0444
rick.wilson@bidgroup.ca
info@alsaction.org

Brittany Mroczek
At-home Parent
ALS Action Canada Executive Committee
Father diagnosed with ALS 2018
2596 163A Street
Surrey, BC V3Z 6X7
604 657 4701
bderby77@gmail.com
bmroczek@alsactioncanada.org

Cc:
Erin O’Toole, M.P., Leader of the Conservative Party of Canada
Jagmeet Singh, M.P., Leader of the New Democratic Party of Canada
Elizabeth May, M.P., Leader of the Green Party Parliamentary Caucus
Yves-Francois Blanchet, M.P., Leader of the Bloc Québécois
Heather McPherson, M.P., Parliamentary ALS Caucus
Todd Doherty, M.P., Parliamentary ALS Caucus
Francis Drouin, M.P., Parliamentary ALS Caucus
Rick Theis, Director of Policy and Cabinet Affairs, Prime Minister’s Office
Steven Schwendt, Director of Operations, Privy Council Office
Sabina Saini, Chief of Staff to the Minister of Health Canada
Dr. Stephen Lucas, Deputy Minister, Health Canada
Pierre Sabourin, Assistant Deputy Minister, Health Canada
Marcel Saulnier, Associate Assistant Deputy Minister, Health Canada
Kathryn Nowers, Director of Policy, Health Canada
Frances Hall, Director, Strategic Policy Branch, Health Canada
Luke Carter, Director, Federal-Provincial-Territorial Relations Division, Health Canada

___________________________________________________________

ABOUT ALS ACTION CANADA

Formed in February 2020, ALS Action Canada is a patient-led organization advocating for urgent access to promising therapies for Canadians living with ALS, more and better clinical trials for ALS therapies in Canada, and increased federal and provincial funding for ALS research.

ALS Action Canada’s Executive Committee includes people and caregivers living with ALS from the professions of law, medicine, pharmacy, physiotherapy, accounting, engineering, and the military. With members from across the country, we are a strong network of Canadian ALS patients and supporters, dedicated to amplifying the voices of, and actively advocating for, the thousands of Canadian families and their communities living with this devastating disease.

www.alsactioncanada.org
Twitter: @ALSaction
Instagram: @ALSaction
Facebook: @ALSActionCanada
#EndALS
#ICBCRebateChallenge

___________________________________________________________

ABOUT ALS


ALS (amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease) is a disease that attacks cells in the body that control movement. It makes the brain stop talking to the muscles, causing increased paralysis over time. Ultimately, ALS patients become prisoners within their own bodies, unable to eat, breathe, or move on their own. Their minds, however, remain sharp, so they are completely aware of what’s happening to them.

Today, ALS is always fatal and patients typically live for 3 to 5 years after diagnosis. That’s because scientists have yet to identify a cure for ALS. The recent acceleration of research has ensured that this will change. It is now not a question of if, but when there will be a significant treatment breakthrough that brings a cure within reach.

[1] www.alsactioncanada.org

[2] www.iamals.org

[3]https://www.businesswire.com/news/home/20210309005180/en/Amylyx-Pharmaceuticals-Plans-Regulatory_Filing-of-AMX0035-for-the-Treatment-of-ALS-in-Canada

[4] https://www.nejm.org/doi/full/10.1056/NEJMoa1916945

[5] https://petitions.ourcommons.ca/en/Petition/Details?Petition=e-2971

[6] https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis

[7] https://www.als.ca/blogs/access-to-therapies-radicava-edaravone-update/

[8] https://www.biogen.com/en_us/als-community-update.html

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