FDA Approves Genzyme's Label Expansion Of MS Drug Aubagio

Sanofi company Genzyme announced the approval of the U.S. Food and Drug Administration (FDA) for the U.S. label of its multiple sclerosis drug Aubagio to include additional safety and efficacy data.

Aubagio (teriflunomide) is a once-daily, oral therapy indicated for the treatment of adults with relapsing forms of multiple sclerosis. The drug is an immunomodulator with anti-inflammatory properties believed to reduce the number of activated immune cells in the central nervous system. Aubagio is approved in over 50 countries including the U.S. and EU.

The new label expansion contains safety and efficacy data from the TOWER and TOPIC studies. Results from the TOWER trial show that Aubagio reduced the yearly rate of relapse as well as relative risk of sustained disability progression versus placebo. Data from the TOPIC study show that a greater number of patients treated with Aubagio experienced freedom from disease relapse compared to placebo. Findings from the TOPIC study were published last month in The Lancet Neurology.

“Aubagio is the only oral multiple sclerosis treatment that has demonstrated a positive effect on disability progression in two Phase 3 clinical studies and is the only oral therapy with supporting published efficacy data on the treatment of patients who have experienced a first clinical attack. These data, along with its consistent safety and tolerability profile, make Aubagio an important treatment option for patients with relapsing MS,” said Dr. Aaron E. Miller, Medical Director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis, The Mount Sinai Hospital.

Safety analyses data were also included in the new label, which shows that the incidence of serious adverse events in patients treated with Aubagio were comparable to those who took placebo.

Genzyme President and CEO, David Meeker, said, “The update to the U.S. label reflects the breadth of data reinforcing the consistent efficacy of Aubagio. Aubagio is establishing itself within the MS treatment paradigm due to its efficacy, as well as its safety and tolerability as demonstrated during its two years on the market.”