Biogen Idec Submits Application for BG-12

Biogen Idec announced last week that they have submitted an application to the United States Food and Drug Administration (FDA) for approval of BG-12 (dimethyl fumarate), an experimental oral drug for the treatment of relapsing-remitting multiple sclerosis (RRMS). The company plans to also submit an application for the same drug to the European Medicines Agency (EMA) shortly. Biogen Idec expects to hear back from these two agencies within a few months regarding the status and potential approval of BG-12.

In clinical trials, including the Phase III DEFINE study (with 1,200 patients) and the Phase III CONFIRM study (with 1,232 patients), BG-12 reduced MS-disease activity significantly, while showing favorable safety and tolerability data. These placebo-controlled trials were conducted globally, studying the effects of 240 mg of BG-12 given (orally) either twice or three times per day over the course of two years. Specifically, in the Phase III DEFINE study, BG-12 reduced relapses by 49 percent, and decreased the rate of disability progression by 38 percent.

According to MSAA’s “MS Research Update,” published in the Summer/Fall 2011 issue of The Motivator, “This drug may have a distinct dual mechanism of action. First, it is an immunomodulator with anti-inflammatory properties. This induces anti-inflammatory cytokines (small proteins that may stimulate or inhibit the function of other cells) and appears to suppress damaging macrophage cell activity. Second, BG-12 may also have neuroprotective effects. This is due to its activation of a substance that is critical for resistance to cellular damage (from what is termed ‘oxidative stress’) as well as for normal immune function.”

The “MS Research Update” also notes that trials to date indicate that BG-12 is safe and that its overall tolerability improves with continued use. Side effects include skin flushing and gastrointestinal symptoms. A Phase III continuation study of 1,700 patients who participated in the DEFINE and CONFIRM studies will evaluate the long-term safety profile of BG-12 as well as its long-term efficacy on clinical outcomes, MRI scans, and quality of life. The study will be completed in June 2013.

For more information, please refer to Biogen Idec’s press release on the submission of BG-12 for FDA approval.

Written by Susan Wells Courtney, MSAA Senior Writer
Reviewed by Jack Burks, MD, MSAA Chief Medical Officer