CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme,
a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today the
European Medicines Agency (EMA) has accepted the filing of the marketing
authorization application (MAA) for once-daily oral teriflunomide for
the treatment of relapsing forms of multiple sclerosis (MS). Acceptance
of the MAA starts the EMA’s review process.
“As an oral therapy
with a promising clinical profile, teriflunomide is extremely well
positioned to provide an alternative therapeutic option to patients who
are currently taking injectable therapies. Those injectable therapies
make up approximately 80 percent of the MS market today.”
“The filing represents another important milestone for teriflunomide
and brings us one step closer to offering a new treatment option to
patients with relapsing MS,” said Bill Sibold, Senior Vice
President, Head of Multiple Sclerosis, Genzyme. “As an oral therapy
with a promising clinical profile, teriflunomide is extremely well
positioned to provide an alternative therapeutic option to patients who
are currently taking injectable therapies. Those injectable therapies
make up approximately 80 percent of the MS market today.”
The purpose of the MAA is to secure approval to market and allow
prescription of teriflunomide in the European Union based on data from
two completed pivotal Phase III trials, TEMSO and TENERE. These trials
represent two of five efficacy studies of teriflunomide in MS that are
completed or underway, making the clinical program one of the largest
and broadest of any MS therapy in development.
An application to market teriflunomide in the United States is under
review by the U.S. Food & Drug Administration.
About Teriflunomide
Teriflunomide is an immunomodulatory, disease-modifying oral drug with
anti-inflammatory properties, and is under investigation for the
treatment of MS. Teriflunomide blocks the proliferation and functioning
of activated T and B lymphocytes – which are thought to be especially
damaging in MS – by selectively and reversibly inhibiting a
mitochondrial enzyme. Slowly dividing or resting lymphocytes are
generally unaffected by teriflunomide, suggesting that the immune
system’s response to infection should not be compromised.
Teriflunomide is being studied in a large clinical program that is
expected to include more than 5,000 trial participants in 36 countries.
Five efficacy clinical trials are either completed or underway with
teriflunomide, making the clinical program one of the largest and
broadest of any MS agent under development. In addition to the TEMSO and
TENERE trials, the Phase III, placebo-controlled trial TOWER is ongoing
in people with relapsing forms of MS. Another Phase III study, TOPIC, is
underway in early MS or CIS (clinically isolated syndrome).
Teriflunomide is also being evaluated as an adjunct therapy to
interferon-β in the Phase III TERACLES trial. With up to 10 years of
continuous use in a Phase II extension, teriflunomide has the longest
clinical experience of any investigational oral MS therapy.
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, rare
diseases, consumer healthcare, emerging markets and animal health.
Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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approval and commercial success of therapeutic alternatives, the Group’s
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