Health Canada

FSD Pharma will soon launch a first-in-human trial testing Lucid-21-302, known as Lucid-MS — its novel chemical treatment for multiple sclerosis (MS) — in healthy volunteers. Health Canada has cleared the company to initiate a Phase 1 clinical trial of the investigational therapy, FSD Pharma announced in a…

Kesimpta (ofatumumab) is now accessible to eligible Canadians with relapsing-remitting multiple sclerosis (RRMS) through public drug plans in Ontario and Quebec. The treatment has been included as an exceptional medication under both the Ontario Drug Benefit Exceptional Access Program and the Régie de l’assurance maladie du Québec. This…

Health Canada has approved Kesimpta (ofatumumab) for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) who have active disease, as defined by clinical and imaging features. In contrast with other B-cell-targeting therapies used in MS, patients can self-administer a precise dose of Kesimpta at home using the Sensoready…

Health Canada has approved Zeposia (ozanimod), an oral daily treatment for people with relapsing-remitting multiple sclerosis (RRMS) in the country. Approval does not assure that Zeposia will be available to Canadian patients at no or low cost, as publicly funded prescription plans are largely administered by each…

MMJ International Holdings announced that it has been given clearance to ship its cannabis-based products to the U.S. for use in future clinical trials of potential cannabis-based treatment for multiple sclerosis (MS) and Huntington’s disease. The process was facilitated by the U.S. Drug Enforcement Agency (DEA), which worked alongside…

Health Canada has approved Novartis‘s Mayzent (siponimod) for the treatment of adults with active secondary progressive multiple sclerosis (SPMS) to delay the progression of physical disability. Active disease is determined either by the presence of relapses or magnetic resonance imaging features characteristic of inflammatory activity. Multiple sclerosis (MS)…

MetP Pharma Awarded US Patent for Potential Remyelination Therapy Mention remyelination and the reaction from most of us with multiple sclerosis is probably, “How soon?” This announcement makes me hope that it’s now a little sooner. The process combines testosterone with a compound that changes the activity of something…

AbobotulinumtoxinA, marketed as Dysport Therapeutic by Ipsen Biopharmaceuticals Canada, was approved by Health Canada for the treatment of lower limb focal spasticity in adults. Focal spasticity is a medical disorder characterized by an abnormal increase in muscular stiffness in one or more muscles, and usually is the result…

MMJ Bio Science has become the first company to obtain a Canadian license to produce medical cannabis, with the initial authorization covering products for multiple sclerosis and Huntington’s disease. The Health Canada license allows the company to extract cannabinoids from plants that it grows to produce therapies that will be tested in U.S.

Primary progressive multiple sclerosis (PPMS) patients in Canada in the earlier stages of this disease can now be treated with Ocrevus (ocrelizumab), following Health Canada‘s decision to approve its use with restrictions. Roche/Genentech’s Ocrevus can be prescribed to adults with early-stage PPMS and characteristic signs of…

Health Canada has approved Ocrevus for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) with active disease, Roche Canada announced. The approval followed the positive results from the Phase 3 OPERA studies, which evaluated the safety and efficacy of Ocrevus in 825 patients with RRMS. The OPERA 1 and OPERA 2 trials showed that Ocrevus significantly reduced disease activity and disability progression of RRMS patients, with annual relapse rates falling by almost half. Moreover, Ocrevus outperformed Rebif, the standard of care in MS, in slowing worsening of disability and significantly reducing lesions seen on MRI scans over a two-year treatment period. "Ocrevus is a major addition to the treatment options available for MS. The RRMS Ocrevus clinical trial data show a significant reduction in relapses and disease progression, as well as a good safety profile," Daniel Selchen, a neurologist and head of the Division of Neurology at St. Michael's Hospital in Toronto, said in a press release. "For appropriate patients, Ocrevus will be of great value in reducing the burden of MS." The treatment's approval, however, did not extend to — or mention — people with primary progressive MS, in contrast to the U.S. Food and Drug Administration's action in March, which approved Ocrevus for both MS forms. Health Canada did not give address PPMS in its announcement. Estimates are that 100,000 Canadians are currently living with MS, and most have the relapsing form. A number welcomed Ocrevus' arrival for what it offers in their fight against this disease.

Health Canada has approved Zinbryta (daclizumab) as a treatment for adults with active relapsing-remitting multiple sclerosis (RRMS), Biogen and AbbVie announced. Zinbryta is a long-acting injection therapy, self-administered monthly, for patients who have had an inadequate response to at least two other MS therapies. “ZINBRYTA™ is the first once-monthly, self-administered treatment…