I am attempting to summarize information on Aubagio. I have not been involved in the Aubagio trials, have no relationship to Sanofi and claim no medical (or any other) expertise.
What is Aubagio?
Teriflunomide is an immunomodulatory, disease-modifying oral drug with anti-inflammatory properties, and is under investigation for the treatment of relapsing-remitting multiple sclerosis (RRMS) and clinically isolated syndrome (CIS).
Aubagio, an oral medication, initially tested as a complimentary medication to Copaxone and interferon patients. This means you would take Aubagio is addition to Copaxone or interferon therapy. The results were encouraging enough to consider the drug as a standalone therapy choice.
Who makes Aubagio?
Sanofi manufactures Aubagio. Sanofi is also the manufacturer of Lemtrada (Campath) another MS medication pending FDA approval.
Is Aubagio new?
Teriflunomide is the active metabolite of leflunomide (a rheumatoid arthritis drug). Aubagio has approximately 10 years of continuous use for MS patients in clinical trials. Teriflunomide is not an approved medication for other conditions.
Is the drug approved?
Aubagio is still under review by the European Union and US Food & Drug Administration. Approval should be expected prior to Q1 of 2013.
How does the drug work?
Aubagio has both immunomodulatory and anti-inflammatory properties. Aubagio:
- blocks the proliferation and functioning of activated T and B lymphocytes by selectively and reversibly inhibiting a critical mitochondrial enzyme.
- reduces inflammation by preventing immune cells dividing (multiplying)
How is Aubagio administered?
Aubagio is a daily oral medication that has been tested in both 7 and 14 mg doses. I will differentiate between the two doses using Au-7 and Au-14.
What Aubagio MS trial have been conducted?
TEMSO, TENERE, TOWER and TERACLES trials were conducted.
What were the trial results?
-> Compared to placebo
Relapses were reduced by 31% when compared with placebo. Relapse rates leading to hospitalization were reduced by 36%. Non-hospital, emergency medical visits were reduced by 42% for Au-14 and 31% for the Au-7 dose.
Overall, the drug reduced areas of active inflammation in the brain, but MRI lesion activity and related brain atrophy rose at both the doses.
EDSS disability scores rose moderately at the Au-7 dosage, but remained stable for Au-14 patients.
-> Compared to Rebif
Overall, the drug has "disappointed" by not proving to be better than Rebif when compared head-to-head. The annual relapse rate was statistically similar for both Rebif and Au-14 and both performed better than Au-7 dose.
Patients were almost three times more likely to discontinue Rebif with compared with Au-7 and were twice more likely than Au-14.
What about side effects?
Teriflunomide has been well tolerated with no major safety concerns.
Common side effects:
The most common side effects experienced by patients were nausea, diarrhea, colds, mild hair loss and/or thinning, back pain and elevated levels of liver enzymes. Between 10-20% of patients indicated they "believed" hair changes were noticeable.
Serious infections were lower for Au-7 than placebo and slightly higher for patients taking Au-14. Three significant kidney infections occurred in the Au-14 patients, but were successfully treated. There were no patient deaths observed in any of the trials
Pregnant women were intentionally excluded from the trial. Approximately 33 women were identified as pregnant during the trial period. A few pregnancies were “spontaneously aborted” while other babies were born healthy and without any detectable abnormalities. The drug leflunomide carries a warning against the use during pregnancy.
Doctors were able to successfully reduce Aubagio system levels by treating with cholestyramine or charcoal after a pregnancy determination was made.
What will Aubagio cost?
There is currently no cost information available.
Will there be a financial assistance program?
At this time, this information is unknown.
What is Aubagio?
Teriflunomide is an immunomodulatory, disease-modifying oral drug with anti-inflammatory properties, and is under investigation for the treatment of relapsing-remitting multiple sclerosis (RRMS) and clinically isolated syndrome (CIS).
Aubagio, an oral medication, initially tested as a complimentary medication to Copaxone and interferon patients. This means you would take Aubagio is addition to Copaxone or interferon therapy. The results were encouraging enough to consider the drug as a standalone therapy choice.
Who makes Aubagio?
Sanofi manufactures Aubagio. Sanofi is also the manufacturer of Lemtrada (Campath) another MS medication pending FDA approval.
Is Aubagio new?
Teriflunomide is the active metabolite of leflunomide (a rheumatoid arthritis drug). Aubagio has approximately 10 years of continuous use for MS patients in clinical trials. Teriflunomide is not an approved medication for other conditions.
Is the drug approved?
Aubagio is still under review by the European Union and US Food & Drug Administration. Approval should be expected prior to Q1 of 2013.
How does the drug work?
Aubagio has both immunomodulatory and anti-inflammatory properties. Aubagio:
- blocks the proliferation and functioning of activated T and B lymphocytes by selectively and reversibly inhibiting a critical mitochondrial enzyme.
- reduces inflammation by preventing immune cells dividing (multiplying)
How is Aubagio administered?
Aubagio is a daily oral medication that has been tested in both 7 and 14 mg doses. I will differentiate between the two doses using Au-7 and Au-14.
What Aubagio MS trial have been conducted?
TEMSO, TENERE, TOWER and TERACLES trials were conducted.
What were the trial results?
-> Compared to placebo
Relapses were reduced by 31% when compared with placebo. Relapse rates leading to hospitalization were reduced by 36%. Non-hospital, emergency medical visits were reduced by 42% for Au-14 and 31% for the Au-7 dose.
Overall, the drug reduced areas of active inflammation in the brain, but MRI lesion activity and related brain atrophy rose at both the doses.
EDSS disability scores rose moderately at the Au-7 dosage, but remained stable for Au-14 patients.
-> Compared to Rebif
Overall, the drug has "disappointed" by not proving to be better than Rebif when compared head-to-head. The annual relapse rate was statistically similar for both Rebif and Au-14 and both performed better than Au-7 dose.
Patients were almost three times more likely to discontinue Rebif with compared with Au-7 and were twice more likely than Au-14.
What about side effects?
Teriflunomide has been well tolerated with no major safety concerns.
Common side effects:
The most common side effects experienced by patients were nausea, diarrhea, colds, mild hair loss and/or thinning, back pain and elevated levels of liver enzymes. Between 10-20% of patients indicated they "believed" hair changes were noticeable.
Serious infections were lower for Au-7 than placebo and slightly higher for patients taking Au-14. Three significant kidney infections occurred in the Au-14 patients, but were successfully treated. There were no patient deaths observed in any of the trials
Note: Many MS drugs carry pregnancy warnings. A woman that is trying to become pregnant, knowns or suspects they are pregnant should ALWAYS consult with their medical team before starting or stopping any medication they are on.
Pregnant women were intentionally excluded from the trial. Approximately 33 women were identified as pregnant during the trial period. A few pregnancies were “spontaneously aborted” while other babies were born healthy and without any detectable abnormalities. The drug leflunomide carries a warning against the use during pregnancy.
Doctors were able to successfully reduce Aubagio system levels by treating with cholestyramine or charcoal after a pregnancy determination was made.
What will Aubagio cost?
There is currently no cost information available.
Will there be a financial assistance program?
At this time, this information is unknown.
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