The Potential for another FDA approval for a New Oral MS Medication

The findings came from open-label extensions of phase II and III studies with teriflunomide, which is now under FDA review as a treatment for relapsing-remitting MS. The results were presented in a series of posters at the joint meeting of the European and American Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Annualized relapse rates during the eight-year extension phase of the phase II study ranged from 0.20 to 0.32, with somewhat lower rates seen with a 14-mg/day dose of teriflunomide relative to 7 mg/day, according to Paul O’Connor, MD, of the University of Toronto, who was a principal investigator for this study and others involving teriflunomide.

The relapse rates were comparable to those seen in the trial’s placebo-controlled phase.

Also, EDSS disability scores remained stable in patients taking 14 mg/day during the extension and rose only moderately among those on 7 mg/day.

But with both dosages, other signs of disease activity, such as total MRI lesion burden and brain atrophy, continued to rise during the extension.