I was asked if I know about the BG-12 Oral and it’s FDA approval status. I Googled BG-12 and found a wonderful resource for all pharmaceuticals! Drugs.com has a search bar to easily find information about all kinds of pharmaceuticals. I simply typed BG-12 in the search bar and was shown all the posts written about BG-12 on Drugs.com.
On Drugs.com I read, “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.”
After extensive research Biogen Idec was ready to have BG-12 submitted to the FDA for approval.
Feb 28, 2012
One of the articles on Drugs.com said, “WESTON, Mass.–(BUSINESS WIRE)–Feb 28, 2012 – 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.”
May 9, 2012
Drugs.com also shared, “May 9, 2012 – Biogen Idec announced that U.S. and EU regulatory authorities have accepted the company’s marketing applications for the review of BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of multiple sclerosis (MS).
“After the regulatory authorities accepted, the U.S. Food and Drug Administration (FDA) then accepted Biogen Idec’s New Drug Application (NDA) for marketing approval of BG-12 in the United States and granted the company a standard review timeline.
“In addition, the European Medicines Agency (EMA) has validated Biogen Idec’s Marketing Authorization Application (MAA) for review of BG-12 in the European Union.
“Biogen Idec’s applications for BG-12 were based on the results demonstrating significant reductions in MS disease activity coupled with favorable safety and tolerability in two pivotal Phase 3 clinical trials. Biogen Idec announced that it submitted an New Drug Application (NDA) to the FDA and an MAA (Marketing Authorization Application) to the EMA (European Medicines Agency) in the first quarter of 2012. The company also recently submitted regulatory applications in Canada and Switzerland.”
Oct 18 2012
Drugs.com also shared, “WESTON, Mass.–(BUSINESS WIRE)–Oct 18, 2012 – Today Biogen Idec announced that the U.S. Food and Drug Administration (FDA) has extended the initial PDUFA (Prescription Drug User Fee Act) date for its review of the New Drug Application (NDA) for the marketing approval of BG-12 (dimethyl fumarate), the company’s oral therapeutic candidate for the treatment of multiple sclerosis (MS).
The 3 month extension is a standard extension period.
The FDA has indicated that the extension of the PDUFA date is needed to allow additional time for review of the application. The agency has not asked for additional studies.
Patients word does matter to the FDA
The Food and Drug Administration (FDA) has a great website and if information on the site can’t be found, we can call the main number for general inquiries 1-888-INFO-FDA (1-888-463-6332)— I couldn’t find any information concerning the approval of BG-12. I was told the FDA only has information about the approved pharmaceuticals.
Even the Biogen idec website has the history of the BG-12 development but it ends in 2011.
So patience is a virtue once again! I’ll keep my eyes open for information about this new oral medication BG-12 that to me looks so promising!