Data from Phase III TOPIC Study of Patients
with First Clinical Episode Suggestive of MS to be Presented at
AAN
Sanofi Genzyme, the specialty care global business unit of
Sanofi, announced today that new investigational data evaluating
the effect of Aubagio® (teriflunomide) on cortical gray matter
atrophy in patients with a first clinical episode suggestive of MS
will be presented at the 69th American Academy of Neurology (AAN)
Annual Meeting.
Data from the Phase III TOPIC study show Aubagio had a
consistent and significant effect on reducing cortical gray matter
atrophy across all time points evaluated over two years. Cortical
gray matter is a part of the central nervous system that makes up
the outer surface of brain tissue of the cerebral hemispheres. Gray
matter is believed to be associated with cognitive function.
Compared to placebo, Aubagio reduced the median percentage of
cortical gray matter atrophy:
Time Point
Aubagio 7 mg relative
reductionvs. placebo
Aubagio 14 mg relative
reductionvs. placebo
At month 6 58.2% (p=0.094)
119.2% (p=0.019) At month 12 79.8%
(p=0.054) 61.4% (p=0.036) At month 18
69.5% (p=0.004) 66.8% (p=0.003)
At month 24 46.0% (p=0.009)
40.2% (p=0.042)
“Accelerated cortical gray matter atrophy can be evident from
the earliest stages of MS, which highlights the need for early
intervention,” said Robert Zivadinov, M.D., Ph.D., Professor of
Neurology at the University of Buffalo, Buffalo, NY. “Pathologic
changes in gray matter are recognized as important contributors to
disease worsening in MS, and strong predictors of potential future
disability and impaired cognitive function. The data being
presented at AAN demonstrating that Aubagio slowed the rate of
cortical atrophy in patients showing early signs of MS are very
promising.”
In the MS clinical studies of Aubagio, including TOPIC, the
incidence of serious adverse events was similar among Aubagio and
placebo-treated patients.
The TOPIC trial was designed to assess whether early initiation
of Aubagio in patients with a first clinical episode suggestive of
MS could prevent or delay a second clinical attack, i.e.,
conversion to clinically definite multiple sclerosis (CDMS).
Patients receiving Aubagio 14 mg and 7 mg in the TOPIC trial were
significantly less likely than placebo (p<0.05) to develop CDMS,
the primary endpoint.
About Aubagio® (teriflunomide)Aubagio
is approved in more than 70 countries, with additional marketing
applications under review by regulatory authorities globally. More
than 70,0001 patients are currently being treated with Aubagio
commercially worldwide.
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.
Aubagio® (teriflunomide) U.S. INDICATIONAUBAGIO®
(teriflunomide) is a prescription medicine used to treat relapsing
forms of multiple sclerosis (MS).
IMPORTANT SAFETY INFORMATION
DO NOT TAKE AUBAGIO IF YOU:
- Have severe liver problems. AUBAGIO
may cause serious liver problems, which can be
life-threatening. Your risk may be higher if you take other
medicines that affect your liver. Your healthcare provider should
do blood tests to check your liver within 6 months before you start
AUBAGIO and monthly for 6 months after starting AUBAGIO. Tell your
healthcare provider right away if you develop any of these symptoms
of liver problems: nausea, vomiting, stomach pain, loss of
appetite, tiredness, yellowing of your skin or whites of your eyes,
or dark urine.
- Are pregnant. AUBAGIO may harm an
unborn baby. You should have a pregnancy test before starting
AUBAGIO. After stopping AUBAGIO, continue to use effective birth
control until you have made sure your blood levels of AUBAGIO are
lowered. If you become pregnant while taking AUBAGIO or within 2
years after stopping, tell your healthcare provider right away and
enroll in the AUBAGIO Pregnancy Registry at 1-800-745-4447, option
2.
- Are of childbearing potential and
not using effective birth control.
It is not known if AUBAGIO passes into breast milk. Your
healthcare provider can help you decide if you should take AUBAGIO
or breastfeed — you should not do both at the same time.
If you are a man whose partner plans to become pregnant,
you should stop taking AUBAGIO and talk with your healthcare
provider about reducing the levels of AUBAGIO in your blood. If
your partner does not plan to become pregnant, use effective birth
control while taking AUBAGIO.
- Have had an allergic reaction to
AUBAGIO or a medicine called leflunomide
- Take a medicine called leflunomide
for rheumatoid arthritis.
AUBAGIO may stay in your blood for up to 2 years after you
stop taking it. Your healthcare provider can prescribe a
medicine that can remove AUBAGIO from your blood quickly.
Before taking AUBAGIO, talk with your healthcare provider if
you have: liver or kidney problems; a fever or infection, or if
you are unable to fight infections; numbness or tingling in your
hands or feet that is different from your MS symptoms; diabetes;
serious skin problems when taking other medicines; breathing
problems; or high blood pressure. Your healthcare provider will
check your blood cell count and TB test before you start AUBAGIO.
Talk with your healthcare provider if you take or are planning to
take other medicines (especially medicines for treating cancer or
controlling your immune system), vitamins or herbal
supplements.
AUBAGIO may cause serious side effects, including:
reduced white blood cell count — this may cause you to have more
infections; numbness or tingling in your hands or feet that is
different from your MS symptoms; allergic reactions, including
serious skin problems; breathing problems (new or worsening) and
high blood pressure. Patients with low white blood cell count
should not receive certain vaccinations during AUBAGIO treatment
and 6 months after.
Tell your doctor if you have any side effect that bothers you or
does not go away.
The most common side effects when taking AUBAGIO include:
headache; diarrhea; nausea; hair thinning or loss; and abnormal
liver test results. These are not all the side effects of
AUBAGIO. Tell your healthcare provider about any side effect that
bothers you.
Consult your healthcare provider if you have questions about
your health or any medications you may be taking, including
AUBAGIO.
You are encouraged to report side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch or
call 1-800-FDA-1088.
Please see full U.S. Prescribing
Information, including boxed WARNING and Medication
Guide.
About SanofiSanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi is organized into five global business
units: Diabetes and Cardiovascular, General Medicines and Emerging
Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer
Healthcare.
Sanofi Genzyme focuses on developing specialty treatments for
debilitating diseases that are often difficult to diagnose and
treat, providing hope to patients and their families. Learn more
at www.sanofigenzyme.com
Sanofi® and Aubagio® are registered trademarks of Sanofi.
Genzyme® is a registered trademark of Genzyme Corporation. All
rights reserved.
1 Company data on file
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defined in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
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Regarding Forward-Looking Statements” in Sanofi’s annual report on
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version on businesswire.com: http://www.businesswire.com/news/home/20170425005095/en/
Sanofi Genzyme Media RelationsRachel Gross,
+1-617-768-6881rachel.gross@sanofi.comorSanofi Media
RelationsAshleigh Koss,
+1-908-981-8745ashleigh.koss@sanofi.comorSanofi Investor
RelationsGeorge Grofik, +33 (0) 1 53 77 45 45ir@sanofi.com
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