Aubagio is the major active metabolite of Arava (leflunomide), Sanofi’s oral treatment for rheumatoid arthritis, and is a dihydroorotate dehydrogenase (DHODH) inhibitor. Although the mechanism of teriflunomide is not fully understood, researchers hypothesize that it suppresses DHODH by selective inhibition of pyrimidine biosynthesis, which modulates the proliferation of B lymphocytes to promote anti-inflammatory and immunosuppressive effects.
Sanofi secured US Food and Drug Administration approval for Aubagio for the treatment of relapsing forms of MS in September 2012, two years after the agency granted approval of Gilenya (fingolimod; Novartis/Mitsubishi Tanabe). As such, Aubagio represents the second-to-market oral disease-modifying drug for relapsing MS. In August 2013, Aubagio received European Commission approval for relapsing-remitting MS, paving the way for launch across Europe. To date, Sanofi has not issued publicly available information to indicate that Aubagio is under development in Japan.
LIST OF FIGURES
9 Figure 36: Zinbryta sales for multiple sclerosis across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES
5 Table 1: Aubagio drug profile
6 Table 2: Aubagio pivotal trial data in multiple sclerosis
14 Table 3: Aubagio sales for multiple sclerosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
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