Aubagio teriflunomide: Additional Phase III data

Additional data from the double-blind, international Phase III TOPIC trial in 618 patients who had experienced their first neurological symptoms consistent with CIS showed that once-daily 7 and 14 mg doses of oral Aubagio each significantly reduced the risk of occurrence of a new clinical relapse or MRI lesion over 2 years vs. placebo. Specifically, Aubagio reduced the risk of occurrence of a new clinical relapse or MRI lesion by 31.4% in the low-dose group (p=0.002) and by 34.9% in the high-dose group (p=0.0003) compared to placebo. Additionally, there was a 5% increase in total lesion volume in patients receiving high-dose Aubagio as measure by MRI over 2 years vs. a 28% increase for placebo (p=0.0374). Furthermore, high-dose Aubagio led to a 59% reduction in gadolinium-enhancing T1 lesions compared to placebo (p=0.0008). The trial enrolled patients who had experienced a first acute or sub-acute, well-defined neurological event consistent with demyelination, as well as onset of MS symptoms within 90 days of randomization and MRI scan showing >=2 T2 lesions characteristic of MS. Data were presented at the European Committee for Treatment and Research in Multiple Sclerosis meeting in Copenhagen. ...