Biogen Idec submits application to FDA for approval of oral BG-12 to treat multiple sclerosis

Today Biogen Idec (NASDAQ: BIIB) announced the company 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 of multiple sclerosis (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.

“While there have been important therapeutic advances in MS over the last 15 years, there is still a significant unmet need for new and innovative therapies that target the disease in different ways,” said Douglas E. Williams, Ph.D., Biogen Idec’s executive vice president of Research and Development. “Based on the robust clinical efficacy and safety data seen in our Phase 3 studies, we believe BG-12 has the potential to become an important oral treatment option for MS patients.”

Biogen Idec 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,” concluded Dr. Williams. “We anticipate hearing from regulatory authorities regarding the status and acceptance of our submissions within the next couple of months.”

About BG-12

BG-12 (dimethyl fumarate) is an investigational oral therapy in late-stage clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS), the most common form of MS. 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 3 clinical trials that evaluated 240 mg of BG-12, administered either twice a day or three times a day, for two years.