Biogen Idec announced that the FDA has approved Tecfidera (dimethyl fumarate) delayed-release capsules as first-line oral treatment for patients with relapsing forms of multiple sclerosis (MS). Tecfidera is a nicotinic acid receptor agonist that activates the Nuclear factor-like2 (Nrf2) pathway, which is involved in the cellular response to oxidative stress.
The approval of Tecfidera is based on data from a clinical development program that included DEFINE and CONFIRM, two global Phase 3 studies that enrolled more than 2,600 patients. In the ongoing extension study, ENDORSE, some patients receiving Tecfidera have been followed for more than four years.
In DEFINE, Tecfidera significantly reduced the proportion of patients who relapsed by 49% (P<0.0001), the annualized relapse rate (ARR) by 53% (P<0.0001), and 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38% (P=0.0050) vs. placebo at two years.
In CONFIRM, twice-daily Tecfidera significantly reduced ARR by 44% (P<0.0001) and the proportion of patients who relapsed by 34% (P=0.0020) vs. placebo at two years. Both studies also showed that Tecfidera significantly reduced lesions in the brain compared to placebo, as measured by magnetic resonance imaging (MRI).
Tecfidera delayed-release capsules will be available in 120mg and 240mg strengths. The 120mg capsules will be available in 14-count bottles, and the 240mg capsules will be available in 46- and 60-count bottles.
For more information call (617) 679-2000 or visit www.tecfidera.com.