Genzyme,
a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the
European Commission has granted marketing authorization for Aubagio®
(teriflunomide) 14 mg, a once-daily, oral therapy indicated for the
treatment of adult patients with relapsing remitting multiple sclerosis
(RRMS).
“The fact that Aubagio 14 mg has demonstrated a positive effect on
disability progression in two phase III clinical studies underscores its
importance as a new treatment option for relapsing remitting MS
patients," said Professor Ludwig Kappos, MD, Chair of
Neurology, University Hospital, Basel, Switzerland. "As a new
once-daily, oral treatment option with well-characterized safety and
tolerability, Aubagio could be an attractive option for patients
dissatisfied with traditional injectable therapies."
The EU approval of Aubagio was based on data from the Phase III TEMSO (TEriflunomide
Multiple Sclerosis
Oral) and TOWER (Teriflunomide
Oral in people With
relapsing remitting multiplE scleRosis)
trials. In these trials, Aubagio significantly reduced the annualized
relapse rate and the time to disability progression at two years versus
placebo.
“Aubagio’s efficacy, safety and convenient dosing may provide an
attractive treatment option for patients,” said Genzyme CEO and
President, David Meeker, M.D. “Today’s approval of Aubagio is another
step forward for Genzyme as we work to develop important new treatments
that can address the diverse needs of the MS community.”
Multiple sclerosis is estimated to affect more than 2.1 million people
globally. There are approximately 630,000 people affected by MS in
Europe.
The development of Aubagio reflects more than a decade of work by the
Sanofi R&D organization.
Aubagio is approved to treat relapsing MS in the United States,
Australia, Argentina, Chile and South Korea, and is under review by
additional regulatory agencies.
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.
EU Indication and Usage
Aubagio (teriflunomide) 14 mg is a once-daily, oral therapy indicated in
the European Union for the treatment of adult patients with relapsing
remitting multiple sclerosis.
U.S. Indication and Usage
Aubagio (teriflunomide) is a once-daily, oral therapy indicated in the
U.S. for the treatment of adult patients with relapsing forms of
multiple sclerosis. The recommended dose of Aubagio is 7 mg or 14 mg
orally once daily.
Important Safety Information About Aubagio
The Aubagio label includes 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. Teriflunomide is the principal active metabolite of
leflunomide, which is indicated in the U.S. and Europe for the treatment
of rheumatoid arthritis. Severe liver injury including fatal liver
failure has been reported in patients treated with leflunomide.
Leflunomide has an estimated 2.1 million patient years of exposure in
rheumatoid arthritis globally since its launch.
Aubagio is contraindicated in patients with severe hepatic impairment,
pregnant women and women of childbearing potential who are not using
reliable contraception, breast feeding women, patients with
immunodeficiency states, patients with significantly impaired bone
marrow function or significant anaemia, leucopenia, neutropenia or
thrombocytopenia, patients with severe active infection until
resolution, patients with severe renal impairment undergoing dialysis
and patients with hypoproteinaemia.
For full prescribing information and more information about Aubagio for
EU patients, please visit: http://ec.europa.eu/health/documents/community-register/html/alfregister.htm
For full prescribing information and more information about Aubagio for
U.S. patients, please visit: http://products.sanofi.us/aubagio/aubagio.pdf
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.
Genzyme® and Aubagio® are registered trademarks of
Genzyme Corporation, a Sanofi company.
About Sanofi
Sanofi, an integrated global 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).
Sanofi 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
assumptions, statements regarding plans, objectives, intentions and
expectations with respect to future financial results, events,
operations, services, product development and potential, and statements
regarding future performance. Forward-looking statements are generally
identified by the words “expects”, “anticipates”, “believes”, “intends”,
“estimates”, “plans” and similar expressions. Although Sanofi’s
management believes that the expectations reflected in such
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, 2012. Other than as required by applicable
law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
Copyright Business Wire 2013