Once-daily medication the only oral treatment to be reimbursed for first-line use
MISSISSAUGA, ON, June 2, 2014 /CNW/ - Genzyme, a Sanofi company, today announced that Québec's "Institut national d'excellence en santé et services sociaux" (INESSS) has recommended AUBAGIO® (teriflunomide) 14 mg be included on the provincial drug formulary as a first-line oral agent for people in the province living with relapsing remitting multiple sclerosis (RRMS). This follows similar decisions by international Health Technology Assessment Agencies in Europe such as NICE in January and Australia at the end of 2013.
AUBAGIO is used as monotherapy for the treatment of RRMS to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
"The Multiple Sclerosis Society of Québec welcomes the INESSS recommendation to add AUBAGIO to Québec's drug formulary. We are delighted with this news since access to treatments for people with MS is paramount," says Louis Adam, General Manager, Multiple Sclerosis Society of Canada, Québec Division.
Effective June, 2, 2014, the INESSS recommendation 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 and the time to disability progression at two years versus placebo in patients with RRMS. In the TOWER trial, AUBAGIO 14 mg significantly reduced the annualized relapse rate and the time to disability progression was statistically significantly sustained versus placebo in patients with RRMS.
"We are very excited that AUBAGIO will be available to all those in Québec who are living with RRMS," said Peter Brenders, General Manager, Genzyme Canada. "We congratulate Québec on its leadership in recognizing the value brought by this important new treatment, not only as an oral alternative to injectables, but as a first line agent for newly diagnosed patients."
As part of its commitment to those living with MS, Genzyme has developed the MS One to One™ program which offers comprehensive information services and ongoing education as well as reimbursement navigation. Staffed by dedicated MS nurses and highly trained representatives, MS One to One provides support for individuals living with MS, their healthcare providers, family and loved ones.
About MS in Canada
With 100,000 Canadians living with MS and three people newly diagnosed every day, Canada has one of the highest prevalence rates in the world. As most people are diagnosed with relapsing MS in their twenties and thirties, MS is the most common neurological disease affecting young adults in Canada.
About AUBAGIO® (Teriflunomide)
Approved in Canada in November, 2013, 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 and are still benefitting from the treatment.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.ca.
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Genzyme® and AUBAGIO® are registered trademarks of Genzyme Corporation. All rights reserved.
SOURCE: Genzyme Canada
For further information: Media Contacts: Noëlle-Dominique Willems, Director Government Affairs and Market Access, Genzyme Canada, (905) 267-3176, [email protected]; Jennifer Dolan, Cohn & Wolfe, (647) 259-3292, [email protected]