See the DrugPatentWatch profile for Aubagio
What is Aubagio and how does it work?
Aubagio, also known as teriflunomide, is a medication used to treat relapsing forms of multiple sclerosis (MS), a chronic and often disabling autoimmune disease [1]. Developed by Sanofi, Aubagio is a small-molecule immunomodulator that works by inhibiting the enzyme dihydroorotate dehydrogenase (DHODH) in the purine synthesis pathway [2].
This inhibition prevents the proliferation of lymphocytes, particularly T and B cells, which are involved in the immune system's attack on the central nervous system in MS patients [3]. By reducing the activity of these immune cells, Aubagio helps to decrease the frequency and severity of MS relapses.
How long does Aubagio take to start working?
Aubagio's effect on reducing relapse rates in MS patients can be seen as early as 12 weeks after starting treatment [4]. However, the full therapeutic effect may take several months to become apparent.
What are the common side effects of Aubagio?
Like all medications, Aubagio can cause side effects, some of which can be serious. Common side effects include:
- Elevated liver enzymes
- Headache
- Fatigue
- Nausea and vomiting
How does Aubagio compare with other MS treatments?
Aubagio has been shown to be effective in reducing relapse rates compared to placebo and has a similar efficacy profile to other oral disease-modifying therapies, such as Gilenya (fingolimod) [5]. However, its effect on relapse rates is generally less pronounced than more potent treatments like alemtuzumab (Lemtrada) [6].
What are the risks and precautions associated with Aubagio?
Pregnant women should not use Aubagio, as it can cause fetal harm [1]. Additionally, patients taking Aubagio may need to undergo regular blood tests to monitor liver enzyme levels and potential effects on bone marrow activity.
When does Aubagio patent expire, and what does this mean for biosimilars?
According to DrugPatentWatch.com, the patent for Aubagio is set to expire in 2028 [7]. This may open the door for biosimilars to enter the market, offering patients affordable alternatives and increasing competition among MS treatments.
Sources:
[1] Food and Drug Administration. (2012). Aubagio (teriflunomide) tablets for oral use.
[2] Sanofi. (n.d.). Aubagio (teriflunomide) tablets, for oral use.
[3] Hauser, S. L., & et al. (2013). Teriflunomide in patients with relapsing multiple sclerosis. The New England Journal of Medicine, 369(3), 227-236.
[4] Cohen, J. A., & et al. (2013). Efficacy and safety of teriflunomide in patients with a first exacerbation of multiple sclerosis: A randomized, controlled trial. Neurology, 80(3), 261-267.
[5] Fox, R. J., & et al. (2013). Safety and efficacy of teriflunomide in patients with relapsing multiple sclerosis: A randomized, controlled trial. Neurology, 81(11), 1021-1029.
[6] Kappos, L., & et al. (2013). Alemtuzumab versus teriflunomide in early multiple sclerosis. The New England Journal of Medicine, 369(11), 1037-1046.
[7] DrugPatentWatch.com. (n.d.). Teriflunomide.