Teriflunomide: Difference between revisions

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<!--Clinical data-->
| tradename = Aubagio
| licence_US = Teriflunomide
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_US = <!-- A / B / C / D / X -->
| pregnancy_category =
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled-->
| legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C -->
| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
| legal_status = Approved
| routes_of_administration = Oral
 
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'''Teriflunomide''' (trade name '''Aubagio''', also known as '''A77 1726''') is the [[active metabolite]] of [[leflunomide]].<ref name="pmid17122964">{{cite journal |author=Magne D, Mézin F, Palmer G, Guerne PA |title=The active metabolite of leflunomide, A77 1726, increases proliferation of human synovial fibroblasts in presence of IL-1beta and TNF-alpha |journal=Inflamm. Res. |volume=55 |issue=11 |pages=469–75 |year=2006 |pmid=17122964 |doi=10.1007/s00011-006-5196-x}}</ref> Teriflunomide was investigated in the [[Phase III clinical trial]] TEMSO as a medication for [[multiple sclerosis]] (MS). The study was completed in July 2010.<ref>[http://clinicaltrials.gov/show/NCT00134563 ClinicalTrials.gov Phase III Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis (TEMSO)]</ref> 2-year results were positive.<ref>{{cite news |url=http://www.genengnews.com/gen-news-highlights/sanofi-aventis-teriflunomide-comes-up-trumps-in-two-year-phase-iii-ms-trial/81244075/ |title=Sanofi-Aventis’ Teriflunomide Comes Up Trumps in Two-Year Phase III MS Trial |date=15 Oct 2010 }}</ref> However, the subsequent TENERE head-to-head superiority 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."<ref name="medpage">{{cite web | url=http://www.medpagetoday.com/MeetingCoverage/CMSC-ACTRIMS/33059 | title=Teriflunomide Modest Help but Safe for MS | work=medpage | date=June 4, 2012 | accessdate=June 04, 2012 | author=Gever, John | source=Joint meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis. report author= Vermersch, Pstrick}}</ref> The drug was approved by the FDA on September 13, 2012.<ref>{{cite press release |url=http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm319277.htm |title=FDA approves new multiple sclerosis treatment Aubagio |publisher=US FDA |accessdate=2012-09-14}}</ref>