CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme,
a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today
that the U.S. Food and Drug Administration (FDA) has approved AUBAGIO®
(teriflunomide) as a new once-daily, oral treatment indicated for
patients with relapsing forms of multiple sclerosis (MS). AUBAGIO has
shown significant efficacy across key measures of MS disease activity,
including reducing relapses, slowing the progression of physical
disability, and reducing the number of brain lesions as detected by MRI.
“The FDA’s approval
of AUBAGIO, a new oral treatment option, is an encouraging advancement
for the MS community and may be a valuable treatment for people living
with this often debilitating disease.”
“We are very excited to introduce AUBAGIO as a new treatment option
that can make a difference in the lives of people with multiple
sclerosis,” said David Meeker, President and CEO, Genzyme. “The
approval of our first MS therapy represents an important milestone for
Genzyme and underscores our commitment to long-term leadership and
partnership in the MS community.”
The FDA approval was based on efficacy data from the TEMSO (TEriflunomide
Multiple Sclerosis
Oral) trial. In the Phase III 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 relapsing forms of multiple
sclerosis. AUBAGIO 7 mg significantly reduced the annualized relapse
rate (p=0.0002) in the trial.
“Many people living with MS struggle with the additional burden of
injectable therapies administered daily to weekly,” said Dr. Aaron
E. Miller, Medical Director, The Corinne Goldsmith Dickinson Center for
Multiple Sclerosis, Mount Sinai Medical Center. “The FDA’s approval
of AUBAGIO, a new oral treatment option, is an encouraging advancement
for the MS community and may be a valuable treatment for people living
with this often debilitating disease.”
The ongoing AUBAGIO clinical development program, involving more than
5,000 patients in 36 countries, is amongst the largest of any MS
therapy. Some patients in extension trials have been treated for up to
10 years.
“We are greatly encouraged to see a new oral therapeutic option
become available to people living with MS,” said Dr. Timothy
Coetzee, Chief Research Officer at the National MS Society. “With
collaborative research underway around the world today, this is an
extremely hopeful time for anyone who is diagnosed with MS.”
The AUBAGIO label includes a boxed warning citing the risk of
hepatotoxicity and, teratogenicity (based on animal data).
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
increased ALT levels, alopecia, diarrhea, influenza, nausea and
paresthesia.
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 U.S. 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.
Please click here
for full Prescribing Information for once-daily oral AUBAGIO
(teriflunomide), including boxed warning and contraindications, for
treatment of Relapsing Multiple Sclerosis.
The AUBAGIO clinical development program in MS also included the
recently reported TOWER study. TOWER assessed the efficacy and safety of
once-daily, oral AUBAGIO in patients with relapsing forms of multiple
sclerosis (MS). In the study, patients receiving teriflunomide 14 mg had
a statistically significant reduction in annualized relapse rate and
risk of disability progression. In addition, a significant reduction in
annualized relapse rate was observed in patients treated with
teriflunomide 7 mg compared to placebo. Adverse events observed in the
trial were consistent with previous clinical trials with teriflunomide
in MS. Analysis of the full TOWER data is ongoing and results will be
presented at a forthcoming scientific meeting.
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).
As part of its commitment to MS patients, Genzyme has developed the MS
One to One™ program. MS One to One provides information about multiple
sclerosis, AUBAGIO and other relevant resources and is available and
staffed by dedicated MS nurses and highly trained representatives who
can provide support for individuals living with MS, their health care
providers, family and loved ones. For more information about these
support services, call the MS One to One line at 1-855-MSOne2One
(1-855-676-6326) Monday through Friday, from 8:30 a.m. to 8:00 p.m. ET.
Information and support are also available at www.MSOnetoOne.com.
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).
Forward Looking Statements
This press release contains forward-looking statements as defined in
the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts.
These statements include projections and estimates and their underlying
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expectations with respect to future financial results, events,
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forward-looking statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various risks
and uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or implied or
projected by, the forward-looking information and statements. These
risks and uncertainties include among other things, the uncertainties
inherent in research and development, future clinical data and analysis,
including post marketing, decisions by regulatory authorities, such as
the FDA or the EMA, regarding whether and when to approve any drug,
device or biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential of
such product candidates, the absence of guarantee that the product
candidates if approved will be commercially successful, the future
approval and commercial success of therapeutic alternatives, the Group’s
ability to benefit from external growth opportunities, trends in
exchange rates and prevailing interest rates, the impact of cost
containment policies and subsequent changes thereto, the average number
of shares outstanding as well as those discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including those
listed under “Risk Factors” and “Cautionary Statement Regarding
Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for
the year ended December 31, 2011. Other than as required by applicable
law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
Genzyme® is a registered trademark. All
rights reserved.
AUBAGIO® is a registered trademark. All
rights reserved.
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