AUBAGIO
Aubagio (teriflunomide) is a pyrimidine synthesis inhibitor indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients. The medication is used to manage several manifestations of the condition, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. As an immunomodulatory agent with anti-inflammatory properties, it provides a therapeutic approach for adults diagnosed with these specific relapsing forms of MS.
How AUBAGIO Works
Teriflunomide functions by inhibiting dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. Although the exact mechanism of action in multiple sclerosis is unknown, the drug's activity may result in a reduction of activated lymphocytes in the central nervous system. Through this inhibition of pyrimidine synthesis, the agent exerts its immunomodulatory and anti-inflammatory effects.
Details
- Status
- Prescription
- First Approved
- 2012-09-12
- Routes
- ORAL
- Dosage Forms
- TABLET
AUBAGIO Approval History
What AUBAGIO Treats
3 indicationsAUBAGIO is approved for 3 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Clinically isolated syndrome
- Relapsing-remitting disease
- Active secondary progressive disease
AUBAGIO Boxed Warning
HEPATOTOXICITY and EMBRYOFETAL TOXICITY Hepatotoxicity Clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with AUBAGIO in the postmarketing setting [see Warnings and Precautions (5.1) ] . Concomitant use of AUBAGIO with other hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monito...
WARNING: HEPATOTOXICITY and EMBRYOFETAL TOXICITY Hepatotoxicity Clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with AUBAGIO in the postmarketing setting [see Warnings and Precautions (5.1) ] . Concomitant use of AUBAGIO with other hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for six months after starting AUBAGIO [see Warnings and Precautions (5.1) ]. If drug induced liver injury is suspected, discontinue AUBAGIO and start an accelerated elimination procedure with cholestyramine or charcoal [see Warnings and Precautions (5.3) ] . AUBAGIO is contraindicated in patients with severe hepatic impairment [see Contraindications (4) ] . Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking AUBAGIO. Embryofetal Toxicity AUBAGIO is contraindicated for use in pregnant women and in females of reproductive potential who are not using effective contraception because of the potential for fetal harm. Teratogenicity and embryolethality occurred in animals at plasma teriflunomide exposures lower than that in humans. Exclude pregnancy before the start of treatment with AUBAGIO in females of reproductive potential. Advise females of reproductive potential to use effective contraception during AUBAGIO treatment and during an accelerated drug elimination procedure after AUBAGIO treatment. Stop AUBAGIO and use an accelerated drug elimination procedure if the patient becomes pregnant [see Contraindications (4) , Warnings and Precautions (5.2 , 5.3) , Use in Specific Populations (8.1 , 8.3) , and Clinical Pharmacology (12.3) ] . WARNING: HEPATOTOXICITY and EMBRYOFETAL TOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity Clinically signi
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AUBAGIO FDA Label Details
ProIndications & Usage
FDA Label (PDF)AUBAGIO ® is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. AUBAGIO is a pyrimidine synthesis inhibitor indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
WARNING: HEPATOTOXICITY and EMBRYOFETAL TOXICITY Hepatotoxicity Clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with AUBAGIO in the postmarketing setting [see Warnings and Precautions (5.1...
AUBAGIO Patents & Exclusivity
Patents (24 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.