Health Canada

Kesimpta Now Reimbursable for Patients in 2 Canadian Provinces

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 RĆ©gie de lā€™assurance maladie du QuĆ©bec. This…

Health Canada OKs Self-administered Kesimpta for Adults With Active RRMS

Health Canada has approvedĀ 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 Approves Oral Zeposia for Adults With RRMS

Health Canada has approvedĀ 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…

Health Canada Approves Mayzent to Treat Active SPMS

Health Canada has approved Novartis‘sĀ MayzentĀ (siponimod)Ā for the treatment of adults with activeĀ secondary progressive multiple sclerosisĀ (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)…

Ocrevus Approved in Canada to Treat Relapsing-Remitting MS

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 ā€” or mention ā€” 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.

Zinbryta Approved in Canada as Once-Monthly Treatment for Relapsing MS

Health CanadaĀ has approved Zinbryta (daclizumab)Ā as aĀ treatment for adults with active relapsing-remittingĀ multiple sclerosis (RRMS), BiogenĀ and AbbVieĀ 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. “ZINBRYTAā„¢ is the first once-monthly, self-administered treatment…