Who Owns Aubagio?

Aubagio's environmental profile is reported under Sanofi's corporate sustainability disclosures. Sanofi has committed to reducing its carbon emissions by 55% by 2030 compared to a 2019 baseline and to achieving carbon neutrality by 2045. These targets cover Sanofi's manufacturing operations globally, including facilities that produce Aubagio active pharmaceutical ingredient and finished tablets.

Sanofi publishes an annual ESG report that includes energy consumption, water usage, and waste data by manufacturing site. Aubagio production facilities in France, Germany, and the United States fall within Sanofi's scope 1 and scope 2 emissions reporting. Sanofi does not publish product-level carbon footprints for individual drugs.

Sanofi has faced recurring criticism from patient advocacy groups regarding the pricing of Aubagio in the United States. MS patient organizations have documented list price increases over multiple years and have raised concerns about out-of-pocket costs for commercially insured and underinsured patients. Sanofi has operated a patient assistance program for Aubagio throughout its commercial history.

Aubagio does not hold any independent third-party sustainability certification at the brand or product level as of June 2026.

Aubagio's most significant recognition events are regulatory approvals and peer-reviewed clinical trial publications, which are the standard benchmarks for pharmaceutical product credibility.

The TEMSO Phase 3 trial results were published in the New England Journal of Medicine in 2011, providing the primary efficacy evidence that supported FDA approval. The New England Journal of Medicine is the highest-impact peer-reviewed journal in clinical medicine. Publication there represents independent scientific validation of the trial's methodology and findings.

The TOWER trial results, published in The Lancet Neurology in 2014, confirmed teriflunomide 14 mg's efficacy in a second large Phase 3 population. Replication in a second independent trial is the standard for establishing treatment-level evidence in neurology.

The FDA approved Aubagio on September 12, 2012. The European Medicines Agency approved it in August 2013. Regulatory approval in both the FDA and EMA jurisdictions, with independent review processes, represents the two most rigorous drug evaluation systems globally.

Aubagio has faced several safety concerns and controversies throughout its history, primarily related to safety warnings, pregnancy risks, and pharmaceutical pricing issues.

Black Box Warning for Hepatotoxicity: Aubagio carries a black box warning for hepatotoxicity (liver damage), requiring regular monitoring of liver function tests before and during treatment. This safety concern has limited the drug's use in patients with pre-existing liver conditions and requires careful patient monitoring.

Teratogenicity Risk: Aubagio carries a black box warning for teratogenicity (risk of birth defects), requiring effective contraception in women of childbearing potential during treatment and for an extended period after discontinuation. The drug's long half-life of 18-19 days means teratogenic effects can persist for months without accelerated elimination procedures.

Accelerated Elimination Procedure Controversy: The requirement for an accelerated elimination procedure using cholestyramine or activated charcoal when rapid drug removal is needed has been criticized as complex and burdensome for patients. This procedure is necessary in cases of pregnancy or serious adverse events but adds complexity to patient management.

Pharmaceutical Pricing Criticism: Aubagio's pricing as a specialty pharmaceutical has faced criticism from patient advocacy groups and healthcare systems concerned about the affordability of MS treatments. The high cost of specialty DMTs has created access barriers for some patients and increased healthcare system costs.

Generic Competition Pressure: As Aubagio's patents approach expiration, the potential entry of generic teriflunomide has created uncertainty about the brand's future market position and pricing power. Sanofi has managed this transition through lifecycle management strategies.

Clinical Efficacy Debates: Some neurologists have questioned Aubagio's efficacy compared to newer high-efficacy MS therapies, particularly as the MS treatment landscape has shifted toward anti-CD20 antibodies and S1P receptor modulators with stronger efficacy profiles.