Is Teriflunomide on the market?

Teriflunomide (Teriflunomide) was approved by the U.S. Food and Drug Administration (FDA) in September 2012 and marketed for use in the United States, asAubagio's trade name is sold and was approved for use in the EU in August 2013. In July 2018, it was approved by the National Medical Products Administration for marketing in China. Teriflunomide is the active metabolite of leflunomide. It plays an immunomodulatory role by inhibiting pyrimidine synthesis and is used to treat multiple sclerosis (MS), especially the relapsing type.

Teriflunomide was studied as a treatment for multiple sclerosis in a phase 3 clinical trialTEMSO. This study was completed in July 2010. Although patients with multiple sclerosis treated with teriflunomide had significantly fewer permanent discontinuations compared with interferon beta-1a, relapse rates were higher with teriflunomide. The FDA label provides important warnings about the risk of hepatotoxicity and teratogenicity in patients taking teriflunomide, and teriflunomide is also contraindicated in severe liver injury due to reports of liver failure and death.

TeriflunomideThe original drug that is marketed in China has passed the medical insurance reimbursement standards and entered the category of Class B medical insurance. It may be limited to multiple sclerosis patients who are ineffective in conventional treatments. However, the reimbursement ratio is different in different regions, and the price after reimbursement is different. The price of the specification14mg*28 tablets per box is around 10,000 yuan, which is expensive. Cheaper generic drugs are also sold in other overseas countries. The pharmaceutical ingredients of generic drugs are basically the same as those of the original drugs. The price of each box of 14mg*30 tablets produced by an Indian pharmaceutical factory is around RMB 800 (the price may fluctuate due to exchange rates).