Canada has one of the world’s highest Multiple Sclerosis (MS) prevalence rates. Some 100,000 Canadians live with the disease, and three people are newly diagnosed each day. Most people are diagnosed with relapsing MS in their twenties and thirties, and MS is the most common neurological disease affecting young adults in Canada.
Genzyme, a Sanofi company, announced January 5 that Nova Scotia has become the first of Canada’s four Atlantic Provinces to include AUBAGIO (teriflunomide) 14 mg treatment on its provincial drug formulary as a first-line oral agent for people in the province living with relapsing remitting multiple sclerosis (RRMS).
AUBAGIO was approved by Health Canada In November 2013 as monotherapy for treatment of patients with RRMS to reduce clinical exacerbation frequency and delay accretion of physical disability. The approval was based on efficacy data from two Phase III clinical trials TEMSO (TEriflunomide Multiple Sclerosis Oral) and TOWER (Teriflunomide Oral in people With relapsing remitting multiple scleRosis). In the TEMSO trial, AUBAGIO 14 mg significantly reduced the annualized relapse rate (p=0.0005) and the time to disability progression (p=0.0279) at two years versus placebo in patients with RRMS. In the TOWER trial, AUBAGIO 14 mg significantly reduced the annualized relapse rate (p=0.0001) and the time to disability progression sustained for 12 weeks (p=0.0442) was statistically significantly reduced versus placebo in patients with RRMS.
“I am pleased that AUBAGIO has gained a listing in Nova Scotia. This recently approved oral medication provides another reasonably safe and effective treatment choice for o ur MS patients.” comments Dr. Virender Bhan, an assistant professor in the Department of Medicine and the Division of Neurology at Dalhousie University in Halifax, Nova Scotia, a Neurologist at the capital city’s QEII Health Sciences Centre, and Director of the Dalhousie Multiple Sclerosis Research Unit (DMSRU).
Dr. Bhan’s research interests include MS epidemiology, efficacy of disease modifying therapies, inhibitors of apoptosis as biomarkers for MS severity and DMT responsiveness, and the effect of co-morbidities in MS. He is active in multi-centre clinical trials for potential DMTs in relapsing and progressive MS.
According to Genzyme, AUBAGIO is an immunomodulator with anti-inflammatory properties, and although the drug’s exact mechanism of action is not fully understood, it may involve reduction in the number of activated lymphocytes in the central nervous system (CNS). Genzyme notes that AUBAGIO is supported by one of the largest clinical trial programs of any MS therapy, with more than 5,000 trial participants in 36 countries. Some patients in extension trials have been treated for up to 10 years.
Described by the National Multiple Sclerosis Society, Aubagio is a pyrimidine synthesis inhibitor — an oral compound that inhibits the function of specific immune cells that have been implicated in MS. It is related to leflunomide, a drug used to treat rheumatoid arthritis. Aubagio can inhibit a key enzyme required by white blood cells (lymphocytes) — which in turn reduces the proliferation of T and B immune cells that are active in MS and also inhibits the production of immune messenger chemicals by T cells.
“The MS Society is pleased that the Province of Nova Scotia remains responsive with their coverage of new treatments, including oral therapies, for those living with multiple sclerosis,” says Dena Simon, President of the MS Society of Canada’s Atlantic Division, “This responsiveness means Nova Scotians living with MS have greater access and more choice when it comes to treatments that manage the effects of their disease. For people with MS who are interested in exploring treatment options, we encourage them to consult with their healthcare team to find the course that is most appropriate for them.”
“We applaud the Government of Nova Scotia, the first jurisdiction in the Atlantic provinces, to make AUBAGIO available to patients suffering from RRMS. With its once-a-day oral regimen, this will provide patients an alternative to injectables,” says Genzyme Canada General Manager Peter Brenders,
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