Health Canada has conditionally approved Qalsody (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS) associated with mutations in the SOD1 gene. Qalsody, designed to lower levels of the toxic protein that drives the disease for these patients, is the first treatment to directly target the…

NeuroSense Therapeutics has initiated the process of applying to Canada’s regulators for early marketing approval of PrimeC in treating amyotrophic lateral sclerosis (ALS), based on positive findings in a Phase 2b clinical trial. The application will be filed under Health Canada’s Notice of Compliance with Conditions policy, which could…

Two Canadian provinces — Prince Edward Island, and Newfoundland and Labrador — are covering the cost of the oral formulation of Radicava (edaravone) for eligible residents with amyotrophic lateral sclerosis (ALS). Patients will have access through their provincial drug plans to Radicava Oral Suspension, developed along with…

New Brunswick is reimbursing, through its public health insurance program, the cost of Albrioza (sodium phenylbutyrate and ursodoxicoltaurine) for eligible residents living with amyotrophic lateral sclerosis (ALS). The Canadian province is the country’s fourth to provide public coverage for the oral therapy — marketed in the U.S.

The ALS Society of Canada (ALS Canada) and Brain Canada are collaboratively investing CA$1.4 million (about $1.1M US) in nine grants for studies ranging from the development of new treatments for amyotrophic lateral sclerosis (ALS) to finding ways to predict disease progression. The ALS Canada Discovery…

An oral suspension form of Radicava (edaravone), an approved treatment of amyotrophic lateral sclerosis (ALS), was favored for patient reimbursement in Canada by a branch of the Canadian Agency for Drugs and Technologies in Health (CADTH). The opinion issued by the CADTH Canadian Drug Expert Committee recommended that Radicava Oral…

Albrioza, an oral therapy for amyotrophic lateral sclerosis (ALS) still widely known as AMX0035, is now commercially available in Canada, its developer, Amylyx Pharmaceuticals, announced. Its market availability comes about 1.5 months after the therapy was conditionally approved by Health Canada for this neurodegenerative disease. The regulatory decision was based on…

Amylyx Pharmaceuticals is seeking approval, in Canada, of its lead candidate AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). This regulatory submission “represents a significant milestone in our efforts to develop a new treatment option for people living with ALS who have no time to wait,” Joshua Cohen, co-founder, co-CEO,…

Amylyx Pharmaceuticals plans to soon apply to Health Canada, requesting approval of oral AMX0035 to treat amyotrophic lateral sclerosis (ALS) based on the findings of the CENTAUR clinical trial. The company will also explore options for early access to the therapy for patients in the country. One possibly route…

Canadian authorities have approved Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea, or excessive drooling, associated with neurological diseases such as amyotrophic lateral sclerosis (ALS). The decision makes Xeomin the first and only neurotoxin for chronic sialorrhea licensed for this indication in Canada. The therapy was…