CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme,
a Sanofi company, (EURONEXT: SAN and NYSE: SNY) announced today
that the Australian Therapeutic Goods Administration (TGA) has approved
AUBAGIO® (teriflunomide) 14 mg as a new once-daily, oral
treatment indicated for patients with relapsing forms of multiple
sclerosis (MS). The TGA approval will enable health professionals to
prescribe AUBAGIO 14 mg in Australia, which is now the second country to
gain marketing authorization for the treatment, following FDA approval
in September.
“We welcome the advent of a new oral treatment option for MS patients in
Australia”
“We are very pleased with the TGA approval of AUBAGIO that makes
available a new option for healthcare professionals, and people living
with MS in Australia who may benefit from this once-daily, oral
treatment,” said Bill Sibold, Head of Multiple Sclerosis, Genzyme. “The
availability of AUBAGIO in the U.S. and subsequent registration in
Australia not only demonstrates our continued progress, it also reflects
our commitment to deliver differentiated treatments and provide access
for patients globally.”
The TGA’s approval of AUBAGIO was based on safety and efficacy data from
the TEMSO (TEriflunomide Multiple Sclerosis Oral)
trial. The ongoing AUBAGIO clinical development program, involving more
than 5,000 patients in 36 countries including Australia, is amongst the
largest of any MS therapy. Some patients in extension trials have been
treated for up to 10 years.
“For some people living with MS, the additional burden of injectable
therapies administered daily to weekly can sometimes be a struggle,”
said Associate Professor John King, Senior Neurologist, Royal Melbourne
Hospital, who participated in the clinical trials for AUBAGIO. “It is
exciting to see a new oral treatment that has been shown to both reduce
relapses and slow the progression of disability. This is an encouraging
development for the MS community.”
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).
“We welcome the advent of a new oral treatment option for MS patients in
Australia,” said Professor Bill Carroll, Chairman of MS Research
Australia. “It is important for people with MS and their clinicians to
have access to a range of well-tolerated and convenient therapies that
may reduce the impact of the disease on their lives and suit their
lifestyle.”
AUBAGIO is marketed in the U.S. and now Australia. Marketing
applications for AUBAGIO are under review by the European Medicines
Agency (EMA) and other regulatory authorities.
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.com.
About Sanofi
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® is a registered trademark. All
rights reserved.
AUBAGIO® is a registered trademark. All
rights reserved.