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5 Apr 2018

Natco launched a generic version of Teriflunomide tablets for the treatment of relapsing and remitting forms of multiple sclerosis in India

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  • Natco Pharma launched a generic version of Teriflunomide for the treatment of relapsing and remitting forms of multiple sclerosis (RRMS), under its brand Denopsy.
  • This is the first oral medicine for RRMS being offered in India in 14 mg and 7 mg tablets.
  • Teriflunomide is sold by Sanofi-Genzyme under the brand name Aubagio, in the US.

About Teriflunomide:

  • Teriflunomide  is the active metabolite of leflunomide.
  • Teriflunomide was investigated in the Phase III clinical trial TEMSO as a medication for multiple sclerosis (MS).
  • The study was completed in July 2010. 2-year results were positive. However, the subsequent TENERE head-to-head comparison trial reported that “although permanent discontinuations [of therapy] were substantially less common among MS patients who received teriflunomide compared with interferon beta-1a, relapses were more common with teriflunomide.”
  • The drug was approved by the FDA on September 13, 2012 and in the European Union on August 26, 2013.
  • Teriflunomide is an immunomodulatory drug inhibiting pyrimidine de novo synthesis by blocking the enzyme dihydroorotate dehydrogenase. It is uncertain whether this explains its effect on MS lesions.
  • Teriflunomide inhibits rapidly dividing cells, including activated T cells, which are thought to drive the disease process in MS. Teriflunomide may decrease the risk of infections compared to chemotherapy-like drugs because of its more-limited effects on the immune system.
  • It has been found that teriflunomide blocks the transcription factor NF-κB. It also inhibits tyrosine kinase enzymes, but only in high doses not clinically used.

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