Biogen has announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of BG-12 (dimethyl fumarate), the company’s oral therapeutic candidate for the treatment MS. The regulatory submission was based on BG-12’s comprehensive development program, in which BG-12 demonstrated significant reductions in MS disease activity coupled with favorable safety and tolerability in the Phase 3 DEFINE and CONFIRM studies.
Biogen Idec says there are plans to submit a Marketing Authorisation Application (MAA) for BG-12 to the European Medicines Agency (EMA) within the coming days.
“The rapid submissions of our BG-12 regulatory packages, which integrated one of the largest placebo-controlled data sets for a filing in MS, reflect our commitment to bringing additional therapies to patients in need as quickly as possible,” says Douglas E. Williams, Ph.D., Biogen Idec’s executive vice president of Research and Development. “We anticipate hearing from regulatory authorities regarding the status and acceptance of our submissions within the next couple of months.”
BG-12 (dimethyl fumarate) is an investigational oral therapy in late-stage clinical development for the treatment of relapsing-remitting MS (RRMS). BG-12 is the only currently known investigational compound for the treatment of RRMS that has experimentally demonstrated activation of the Nrf-2 pathway. In 2011, Biogen Idec announced positive data from DEFINE and CONFIRM, two global, placebo-controlled phase III clinical trials that evaluated 240 mg of BG-12, administered either twice a day or three times a day, for two years.