Once-daily Aubagio is the only oral treatment to significantly
slow progression of disability in two Phase III studies of patients with
relapsing multiple sclerosis (TEMSO and TOWER), and to have positive
data on early MS (TOPIC) in its label
Company Website:
http://www.genzyme.com
CAMBRIDGE, Mass. -- (Business Wire)
Genzyme,
a Sanofi company, announced today that the Food and Drug Administration
(FDA) has approved the inclusion of efficacy and safety data from the
TOWER and TOPIC studies of once-daily, oral Aubagio®
(teriflunomide) in the product’s U.S. label.
In the TOWER study, patients with relapsing MS receiving Aubagio 14 mg
had a statistically significant reduction in annualized relapse rate and
relative risk of sustained disability progression compared to placebo.
In addition, a significant reduction in annualized relapse rate was
observed in patients treated with Aubagio 7 mg compared to placebo.
The TOPIC study was designed to assess whether initiation of Aubagio in
patients who experienced their first neurological symptoms suggestive of
MS could prevent or delay a second clinical attack (i.e., relapse). In
this study, the proportion of patients free of relapse was statistically
significantly greater for Aubagio 14 mg and 7 mg, compared to placebo.
Results of the TOPIC study were published in The Lancet Neurology
in September 2014.
“Aubagio is the only oral multiple sclerosis treatment that has
demonstrated a positive effect on disability progression in two Phase
III clinical studies and is the only oral therapy with supporting
published efficacy data on the treatment of patients who have
experienced a first clinical attack,” said Dr. Aaron E. Miller,
Medical Director, The Corinne Goldsmith Dickinson Center for Multiple
Sclerosis, The Mount Sinai Hospital. “These data, along with its
consistent safety and tolerability profile, make Aubagio an important
treatment option for patients with relapsing MS.”
Aubagio was approved by the FDA in September 2012 based on data from the
Phase III TEMSO study, in which patients with relapsing MS who received
Aubagio 14 mg had a statistically significant reduction in annualized
relapse rate and relative risk of sustained disability progression
compared to placebo. Patients who received Aubagio 7 mg had a
statistically significant reduction in annualized relapse rate compared
to placebo.
“The update to the U.S. label reflects the breadth of data
reinforcing the consistent efficacy of Aubagio,” said Genzyme
President and CEO, David Meeker, M.D. “Aubagio is establishing itself
within the MS treatment paradigm due to its efficacy, as well as its
safety and tolerability as demonstrated during its two years on the
market.”
Pooled safety analyses from more than 2,000 patients who received
Aubagio in all three Phase III studies were added to the label. In the
MS clinical studies with Aubagio, the incidence of serious adverse
events were similar among Aubagio and placebo-treated patients. Serious
events may include decreased white blood cell count, peripheral
neuropathy, skin reactions and increased blood pressure. The most common
adverse events associated with Aubagio in MS patients included headache,
diarrhea, nausea, alopecia and increase in ALT.
About Aubagio® (teriflunomide)
Aubagio is approved in more than 50 countries around the world,
including the United States, European Union, Australia, Argentina,
Brazil, Canada, Chile, Columbia, Dominican Republic, Guatemala,
Honduras, Mexico, New Zealand, Panama, Peru, Russia, South Korea,
Switzerland, Turkey and Ukraine, with additional marketing applications
under review by regulatory authorities globally. Between clinical trials
and commercial use, approximately 30,000 patients have been treated with
Aubagio.
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.
U.S. Indication and Usage
Aubagio (teriflunomide) is a once-daily, oral therapy indicated 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 the United States, this
information can be found in the boxed warning.
In MS clinical studies with Aubagio, the incidence of serious adverse
events were similar among Aubagio and placebo-treated patients. Serious
events may include decreased white blood cell count, peripheral
neuropathy, skin reactions and increased blood pressure. The most common
adverse events associated with Aubagio in MS patients included headache,
diarrhea, nausea, alopecia and increase in ALT.
Teriflunomide is the principal active metabolite of leflunomide, which
is indicated in the U.S. for the treatment of rheumatoid arthritis.
Severe liver injury including fatal liver failure has been reported in
patients treated with leflunomide. ALT should be monitored monthly for
at least 6 months in patients who start treatment with Aubagio.
Aubagio is contraindicated in patients with severe hepatic impairment,
pregnant women and women of childbearing potential who are not using
reliable contraception and in patients who are taking leflunomide.
Aubagio is not recommended for breast-feeding women, patients with
immunodeficiency states, patients with significantly impaired bone
marrow function or significant anemia, leucopenia, neutropenia or
thrombocytopenia, patients with severe active infection until
resolution, patients with severe renal impairment undergoing dialysis
and patients with hypoproteinaemia.
About MS One to One®
Genzyme’s MS One to One® program provides information
about multiple sclerosis, Aubagio, and other relevant resources. MS
One to One 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
8:30am – 8:00pm ET. Information and support are also available at www.MSOnetoOne.com.
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.
Dr. Miller receives financial compensation as a consultant from Genzyme
and other companies which either develop or assess medicines used for
the treatment of multiple sclerosis.
Genzyme®, Aubagio® and MS One to One®
are registered trademarks of Genzyme Corporation. All rights reserved.
About Sanofi
Sanofi, a 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, 2013. Other than as required by applicable
law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
Contacts:
Genzyme Media Relations
Erin Pascal, +1-617-768-6864
erin.pascal@genzyme.com
Source: Genzyme
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