Teriflunomide is a once-daily oral agent that has been licensed in the EU since 
August 2013 for the treatment of adult patients with relapsing-remitting 
multiple sclerosis (RRMS). More recently (September 2014), the EU summary of 
product characteristics (SmPC) was updated to include data from patients with a 
first clinical demyelinating event. This review examines the EU SmPC for 
teriflunomide, with reference to key clinical and safety outcomes and practical 
considerations for prescribing physicians. In two phase III trials (TEMSO and 
TOWER) in patients with relapsing forms of MS, teriflunomide 14 mg significantly 
reduced the annualized relapse rate and the risk of confirmed disability 
progression sustained for at least 12 weeks. Magnetic resonance imaging (MRI) 
total lesion volume, gadolinium-enhancing lesions, and unique active lesions 
were reduced with teriflunomide treatment in TEMSO. In the TOPIC study, in 
patients with a first clinical demyelinating event, teriflunomide treatment 
significantly reduced the time to a second clinical episode (relapse). Across 
the clinical studies, teriflunomide was generally well tolerated; adverse events 
reported in ≥ 10% of teriflunomide-treated patients were diarrhea, nausea, 
increased alanine aminotransferase, and alopecia. Data from the clinical 
development program support the use of teriflunomide in a broad spectrum of 
patients with RRMS.