Aubagio teriflunomide: Phase III data
Top-line 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 met the primary endpoint of reducing the risk of conversion to clinically definite MS over 2 years vs. placebo. Specifically, Aubagio led to placebo-adjusted reductions in the risk of conversion to clinically definite MS of 37% in the low-dose group (p=0.0271) and 43% in the high-dose group (p=0.0087). The most common adverse events reported in patients receiving Aubagio were alanine transaminase (ALT) elevations, nasopharyngitis, headache, hair thinning, diarrhea and paresthesia. There were no deaths in the Aubagio arms and 1 death due to suicide in the placebo arm. 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. Sanofi's Genzyme Corp. unit said it plans to submit the data to regulatory authorities for "label consideration," but declined to provide details. ...