With 100,000 Canadians living with Multiple Sclerosis (MS), and three people newly diagnosed every day, Canada has one of the highest prevalence rates for the disease in the world. 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 November 20th that the Canadian province of Ontario Public Drug Benefit Program has included AUBAGIO (teriflunomide) 14 mg on the provincial drug formulary as a first-line oral agent for people in the Canadian province living with relapsing remitting multiple sclerosis (RRMS) under its exceptional access program (EAP) for frequently requested drugs. For more information on the updated EAP reimbursement criteria, visit: http://bit.ly/1qIhNN3
Genzyme’s AUBAGIO (teriflunomide) 14 mg was approved by Health Canada In November 2013 as monotherapy for treatment of patients with RRMS to reduce the frequency of clinical exacerbations and to delay the accumulation 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 (see more on these trials below).
“Finally, Ontario patients will have access to what is proving to be the simplest, safest and most consistently effective oral medication for the treatment of relapsing MS,” says Dr. Mark S. Freedman, a Professor of Neurology at the University of Ottawa.
According to Genzyme, AUBAGIO is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for AUBAGIO is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS). AUBAGIO is supported by one of the largest clinical 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 isa pyrimidine synthesis inhibitor, is 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.
Aubagio was approved by the U.S. Food and Drug Administration (FDA) in September, 2012 for patients with relapsing forms of multiple sclerosis. In one phase III study involving 1088 people with relapsing MS (796 completed the trial), oral Aubagio reduced relapses compared with placebo over at least 108 weeks. Of two different doses tested during the TEMSO trial (7 mg and 14 mg), the higher dose also slowed progression of disability. Both doses also had a favorable effect on several MRI measures, including a smaller increase in total lesion volume and fewer new and actives lesions compared with placebo.
Two subsequent phase III trials have been published and the FDA approved inclusion of these trial results in the prescribing information for Aubagio in 2014. New information includes the ability of Aubagio to reduce the risk of relapse in people who have experienced a first clinical event suggestive of MS (clinically isolated syndrome).
We are sorry that this post was not useful for you!
Let us improve this post!
Tell us how we can improve this post?