■ Sanofi Genzyme Global

AUBAGIO® (teriflunomide) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS).

Do not take AUBAGIO if you have severe liver problems, are pregnant or of childbearing potential and not using effective birth control, have had an allergic reaction to AUBAGIO or leflunomide, or are taking a medicine called leflunomide for rheumatoid arthritis. View IMPORTANT SAFETY INFORMATION

AUBAGIO® (teriflunomide) 14 mg tablet image

Patient Portrayal

Results =
Confidence. Clinical Data.

AUBAGIO was studied versus placebo

  • AUBAGIO® was studied versus placebo in 3 clinical trials: TEMSO, TOWER, & TOPIC In 3 clinical trials
  • AUBAGIO® was studied versus placebo with more than 2800 patients With more than 2,800 people
  • AUBAGIO® was studied versus placebo for up to 108 weeks For up to 108 weeks
  • AUBAGIO® was studied versus placebo in both the 14 mg % 7 mg doses In doses of 14 mg & 7 mg

AUBAGIO® (teriflunomide) 14 mg was shown to be effective vs. placebo in 3 key measures: relapses, disability progression, and brain lesions. AUBAGIO 7 mg was shown to be effective vs. placebo in 2 of the 3 key measures — relapses and brain lesions.

1st Clinical Trial: TEMSO

1,088 PEOPLE

who had at least 1 relapse during 1 year prior to trial, or 2 relapses during 2 years prior to trial
2nd Clinical Trial: TOWER

1,165 PEOPLE

who had at least 1 relapse during 1 year prior to trial, or 2 relapses during 2 years prior to trial
3rd Clinical Trial: TOPIC

614 PEOPLE

who had their 1st clinical event within 3 months prior to trial, and 2 or more lesions characteristic of relapsing MS

*The clinical trials were each given a name. Trial 1 was called TEMSO; Trial 2 was called TOWER; and Trial 3 was called TOPIC.

Aubagio quietsMS in three ways.*

AUBAGIO® quiets relapses

Quiets Relapses

AUBAGIO® slows disability progression

Quiets
Disability Progression‡

AUBAGIO® lessens new active lesions

Quiets New
Lesions

*AUBAGIO is effective across key measures of disease activity: sustained disability progression† (14 mg only), annualized relapse rate, and MRI activity. Overall discontinuation rates due to adverse events were 12.5% with AUBAGIO 14 mg, 11.2% with AUBAGIO 7 mg, and 7.5% with placebo, and discontinuation rates due to common adverse events were ≤3.3% in the pooled clinical trials.

†Doctors measure disability progression using a test called the Expanded Disability Status Scale, or EDSS. Your first score—or your “baseline”—will determine how your disability is gauged moving forward. If your baseline score is ≤5.5, you’re considered to have sustained disability progression if that score goes up by one point (lasting at least 12 weeks). If your baseline score is >5.5, you’re considered to have sustained disability progression if that score goes up by at least 0.5 point (lasting at least 12 weeks).

‡14 mg only.

Ask your doctor if AUBAGIO is right for you.

Free of relapses.

In all 3 clinical trials, AUBAGIO kept more patients relapse-free vs. placebo.

If you are concerned about relapses, ask your healthcare provider if once-daily AUBAGIO may be right for you.

Clinical Trial 1
57%Remained
Relapse-Free
57% remained relapse free in clinical trial #1

on AUBAGIO 14 mg vs. 46% with placebo.

54% remained relapse-free on AUBAGIO 7 mg vs. 46% with placebo.

Clinical Trial 2
57%Remained
Relapse-Free
57% remained relapse free in clinical trial #2

on AUBAGIO 14 mg vs. 47% with placebo.

58% remained relapse-free on AUBAGIO 7 mg vs. 47% with placebo.

Clinical Trial 3
72%Remained
Relapse-Free
72% remained relapse free in clinical trial #3

on AUBAGIO 14 mg vs. 62% with placebo.

71% remained relapse-free on AUBAGIO 7 mg vs. 62% with placebo.


In the 2 clinical trials with people diagnosed with relapsing MS, AUBAGIO was proven to reduce the risk of relapse vs. placebo.

Clinical Trial 1
31%Reduction
In relapse rate
31% reduction in relapse rate in clinical trial #1

on AUBAGIO 14 mg and 7 mg vs. placebo.

Clinical Trial 2
36%Reduction
in relapse rate
36% reduction in relapse rate in clinical trial #2

on AUBAGIO 14 mg vs. placebo.

22% reduction in relapse rate on AUBAGIO 7 mg vs. placebo.

REDUCED RELAPSES OVER TIME.

People experienced about 1 relapse every 6 years on AUBAGIO 14 mg, in the extension study of clinical trial 1.

This extension study followed participants who stayed on AUBAGIO 5.5 years after the original study.

Original Clinical Trial 1 Clinical Trial 1 Extension Study
Annualized relapse Rate (ARR)
(±95% CI)
Clinical trial 1 extension study (total duration about 7.5 years) showed that the rate of relapses decreased over time Clinical trial 1 extension study (total duration about 7.5 years) showed that the rate of relapses decreased over time
total duration: about 7.5 years
  • An extension study follows participants after the original clinical trial has ended and looks at their long-term experience with the medication
  • Everybody in the extension study took AUBAGIO. Participants who were given a placebo (a pill that does not contain medicine) in the original clinical trail were switched to AUBAGIO
  • The people who stayed in the extension study came in for follow-ups, so researchers could learn more about the long-term safety and effectiveness of AUBAGIO

Slowed disability progression.

AUBAGIO 14 mg was shown to help keep patients free of disability progression.

Disability progression was looked at in 2 of the clinical trials. In both of those trials, AUBAGIO 14 mg was shown to help keep more people free from disability progression.

AUBAGIO 7 mg did not achieve a statistically significant reduction in risk of sustained disability progression.

Clinical Trial 1
80%had no
Disability
Progression
80% had no disability progression in clinical trial #1

with AUBAGIO 14 mg vs. 73% with placebo.

78% remained free of disability progression with AUBAGIO 7 mg vs. 73% with placebo.

Clinical Trial 2
84%had no
Disability
Progression
84% had no disability progression in clinical trial #2

with AUBAGIO 14 mg vs. 80% with placebo.

79% remained free of disability progression with AUBAGIO 7 mg vs. 80% with placebo.


Slowed disability progression for up to 7.5 years.

61% showed no disability progression on AUBAGIO 14 mg for up to 7.5 years.

If you’re concerned about disability progression, take a look at this study. The results will be meaningful to you. The study found that the majority of participants showed no disability progression for up to 7.5 years — the treatment was AUBAGIO.

Original Clinical Trial 1 Clinical Trial 1 Extension Study
EDSS Score Change From Baseline
(Mean ± SE)
Clinical trial 1 extension study (total duration about 7.5 years) showed that most people demonstrated no loss of ability during 7.5 years of treatment Clinical trial 1 extension study (total duration about 7.5 years) showed that most people demonstrated no loss of ability during 7.5 years of treatment
total duration: about 7.5 years
  • This extension study of Clinical Trial 1 followed participants who stayed on AUBAGIO — and those who changed from placebo to AUBAGIO — to examine long-term experience with AUBAGIO
  • The graph above shows results for people who took AUBAGIO during both the clinical trial and the extension study
  • Among people who started with placebo and then changed to AUBAGIO, 59% taking the 14 mg pill and 54% taking the 7 mg pill remained free of disability progression for up to 7.5 years

DECREASED THE NUMBER OF NEW LESIONS.§

One clinical trial looked at brain lesions as a key measure of disease activity.

Patients taking AUBAGIO experienced less risk of new brain lesions vs. placebo.

§AUBAGIO is effective against MRI activity.

Clinical Trial 1
80%Fewer
New
Lesions†
80% fewer new active lesions in clinical trial #1

with AUBAGIO 14 mg vs. placebo.

57% fewer new lesions with AUBAGIO 7 mg vs. placebo.

†Average contrast enhancing lesions per scan


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INDICATION

AUBAGIO® (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 may report side effects to the FDA at 1‑800‑FDA‑1088.

Please click here for full Prescribing Information, including boxed WARNING and Medication Guide.

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. View More