Priority review granted in light of limited options to treat the disease
OTTAWA, Oct. 4, 2018 /CNW/ - Amyotrophic Lateral Sclerosis (ALS) is a debilitating degenerative disease that gradually causes muscle weakness and disability. Health Canada recognizes that patients with ALS and their families are anxious to access drugs that could help.
Given the limited treatment options for patients with ALS, Health Canada reviewed the drug edaravone through its priority review process, which accelerates access to drugs and medical devices for Canadians. This means that the Department completed its review of the drug in 180 days, rather than the typical 300 days. As of today, edaravone is approved for sale in Canada for the treatment of ALS.
While its priority review was ongoing, Health Canada also worked with the manufacturer of edaravone and the ALS network to make the drug available through the Department's Special Access Programme (SAP). Health Canada will continue to work with the manufacturer to facilitate access to edaravone until the authorized drug is available on the Canadian market, reimbursement recommendations have been issued by the Canadian Agency for Drugs and Technologies in Health (CADTH) and l'Institut national d'excellence en santé et en services sociaux (INESSS), and funding decisions have been made by public and private drug plans.
Health Canada is committed to prioritizing the review of certain drugs when there are limited treatment options available.
Quick Facts
Product Monograph
SOURCE Health Canada
OTTAWA, Oct. 4, 2018 /CNW/ - Amyotrophic Lateral Sclerosis (ALS) is a debilitating degenerative disease that gradually causes muscle weakness and disability. Health Canada recognizes that patients with ALS and their families are anxious to access drugs that could help.
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Given the limited treatment options for patients with ALS, Health Canada reviewed the drug edaravone through its priority review process, which accelerates access to drugs and medical devices for Canadians. This means that the Department completed its review of the drug in 180 days, rather than the typical 300 days. As of today, edaravone is approved for sale in Canada for the treatment of ALS.
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While its priority review was ongoing, Health Canada also worked with the manufacturer of edaravone and the ALS network to make the drug available through the Department's Special Access Programme (SAP). Health Canada will continue to work with the manufacturer to facilitate access to edaravone until the authorized drug is available on the Canadian market, reimbursement recommendations have been issued by the Canadian Agency for Drugs and Technologies in Health (CADTH) and l'Institut national d'excellence en santé et en services sociaux (INESSS), and funding decisions have been made by public and private drug plans.
Health Canada is committed to prioritizing the review of certain drugs when there are limited treatment options available.
Quick Facts
- ALS (also known as Lou Gehrig's disease) is a disease that gradually causes muscle weakness and disability because the brain progressively loses its capacity to communicate with the muscles of the body. Over time, patients living with ALS will typically experience a progressive loss of their ability to walk, talk, eat, swallow, and eventually breathe.
- An estimated 3,000 Canadians are currently living with ALS. Most people with ALS will die within a few years of the diagnosis.
- To further reduce any potential delays in accessing edaravone, the Canadian Agency for Drugs and Technologies in Health (CADTH) and l'Institut national d'excellence en santé et en services sociaux (INESSS) started reviewing the drug for possible reimbursement through publicly funded drug plans while Health Canada's review was still underway.
- As it does with all drugs authorized for sale in Canada, Health Canada will continue to monitor edaravone for any safety concerns and will take appropriate action if required.
Product Monograph
SOURCE Health Canada
