FDA approves teriflunomide

FDA approves teriflunomide (Aubagio) for the treatment of RRMS. 

“This is good news for MSers living the United States and augurs well for the EMA assessment of teriflunomide in Europe. Teriflunomide is an alternative to the injectables as a first-line agent for RRMS.”

Other relevant posts on this blog in relation to teriflunomide:

26 Jun 2012
Background:The Teriflunomide Multiple Sclerosis Oral (TEMSO) trial, a randomized, double-blind, placebo-controlled phase III study, demonstrated that teriflunomide significantly reduced annualized relapse rate (ARR), 
07 Jun 2012
MSers receiving teriflunomide 14 mg had a statistically significant reduction in annualised relapse rate and risk of sustained accumulation of disability. This double-blind, multi-center trial enrolled 1,169 MSers and compared 
06 Jun 2012
METHODS: A total of 118 MSers with RMS were randomly assigned 1:1:1 to receive oral placebo or teriflunomide, 7 or 14 mg, once daily for 24 weeks; 86 MSers entered the 24-week extension. The primary objective was to 
09 Feb 2012
Although Teriflunomide may appear to be relatively safe, the issue of level of efficacy may determine how well this orally-active compound is recieved. So whilst teriflunomide is effective it is not that effective. In the initial phase 
21 Oct 2009
Data from the cladribine and fingolimod phase III trials were presented at the congress, as well as the phase II trial with teriflunomide and new data illustrating the mechanism of action of laquinimod. Prof. Giovannoni (London 
30 May 2011
Teriflunomide 32% 30% Please remember that all agents are associated with particular side-effects and other attributes; hence the decision on which one is more appropriate for a particular person will require some careful 
06 Aug 2012
The drugs concerned are teriflunomide, BG12, laquinimod and alemtuzumab. Is this good or bad news? This will depend on whether you are keen to get access to these drugs sooner than later. According to NICE the STA 
16 Feb 2011
Sanofi on the other hand are developing Teriflunomide, an oral disease-modifying therapy, that has been reported to reduce the attack rate in relapsing-remitting MS compared to placebo by about 30%. How will Sanofi 

Source: Bloomberg

CoI: Multiple, The Royal London Hospital was a site for several of the Teriflunomide trials – Dr Ben Turner was the principal investiagtor on these studies.

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