MISSISSAUGA, ON, Nov. 20, 2013 /CNW/ - Genzyme, a Sanofi company,
announced today that Health Canada has approved AUBAGIO®
(teriflunomide) 14 mg as monotherapy for the treatment of patients with
relapsing remitting multiple sclerosis (RRMS) to reduce the frequency
of clinical exacerbations and to delay the accumulation of physical
"There are many patients who simply cannot tolerate injections and have
had no simple, effective, once daily oral medication until now," said
Dr. Mark Freedman, Director, Multiple Sclerosis Research Unit and
Professor of Neurology and Senior Scientist at the University of Ottawa
and Ottawa Hospital Research Institute. "As a new oral treatment
option, AUBAGIO is an important advancement for the MS community and
may help improve quality of life for people living with this
The Health Canada 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.
"MS impacts each person differently, which is why increased options are
important when it comes to making personal treatment decisions. The
more treatment options that are available the more choices Canadians
living with MS have to potentially improve their overall quality of
life," said Dr. Karen Lee, Vice-President, Research, Multiple Sclerosis
Society of Canada. "As we learn more about MS and develop therapies
that reduce the frequency and severity of relapses in
relapsing-remitting MS, we hope that we'll also uncover treatments for
people whose disease is steadily progressing."
New positive data from the TOPIC study of AUBAGIO was presented at the
29th Congress of the European Committee for Research and Treatment in
Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark. The double-blind,
multi-centre trial enrolled 618 patients who had experienced a first
acute or sub-acute, well-defined neurological event consistent with
demyelination as well as onset of MS symptoms within 90 days of
randomization, and MRI scan showing two or more lesions characteristic
of MS. The two-year study was designed to assess whether early
initiation of AUBAGIO in patients who experienced their first
neurological symptoms suggestive of MS could prevent or delay a second
The TOPIC study found AUBAGIO 14 mg significantly reduced the risk of a
new clinical relapse over the two-year study period. There was a 35 per
cent reduction among patients who received AUBAGIO 14 mg compared to
"We are very excited that AUBAGIO will be available for Canadians living
with RRMS," said Peter Brenders, General Manager, Genzyme Canada.
"Health Canada's approval of our first MS therapy represents an
important milestone for us, and we are proud of our commitment to
long-term leadership and partnership with the MS community."
As part of its commitment to MS patients, Genzyme has developed the MS
One to One™ program. MS One to One will offer comprehensive support
services, including: reimbursement navigation and other financial
assistance, patient education and compliance services, medication
delivery, and facilitation of the accelerated elimination procedure.
Staffed by dedicated MS nurses and highly trained representatives, MS
One to One can provide support for individuals living with MS, their
health care providers, family and loved ones. Please consult your
healthcare provider for more information.
In MS clinical studies with AUBAGIO, the incidence of serious adverse
events were similar among AUBAGIO and placebo-treated patients. The
most common adverse events associated with AUBAGIO in MS patients
included alopecia, diarrhea, increased ALT levels, headache and nausea.
The AUBAGIO label includes a boxed warning citing the risk of
hepatotoxicity and teratogenicity (based on animal data).
The labeling for AUBAGIO was also informed by the estimated 2.1 million
years of patient exposure globally since the launch of leflunomide,
which is indicated in the US for the treatment of rheumatoid arthritis.
Teriflunomide is the principal active metabolite of leflunomide. Severe
liver injury including fatal liver failure has been reported in
patients treated with leflunomide.
AUBAGIO is also approved in the United States, Europe, Australia,
Argentina, Chile, South Korea and Mexico for the treatment of relapsing
forms of MS. Marketing applications for AUBAGIO are also under review
by additional regulatory authorities globally.
About MS in Canada
With 100,000 Canadians living with MS and three people newly diagnosed
every day, Canada has one of the highest rates in the world. As most
people are diagnosed with relapsing MS in their 20s and 30s, MS is the
most common neurological disease affecting young adults in Canada.
About AUBAGIO® (Teriflunomide)
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.
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
Genzyme® and AUBAGIO® are registered trademarks of Genzyme Corporation.
All rights reserved.
For further information:
Director Government Affairs and Market Access, Genzyme Canada
Account Coordinator, Cohn & Wolfe