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American pharmaceutical manufacturer Biogen Idec, Inc. of Weston, Massachusetts, recently announced it would offer a substantial discount for its new multiple sclerosis (MS) drug Tecfidera, approved for use March 27, 2013 by the US Food and Drug Administration. The medication is also known as BG-12.
A Disease Caused By An Overactive Immune System
MS affects about 400,000 people in the United States and about 2,000,000 people worldwide, most of them in northern Europe and the northern half of the United States along with all of Canada. Typically striking its victims in their 20's, MS results from a hyperactive immune system's attack on the myelin insulation of nerve cells, also known as neurons, causing difficulty walking, loss of vision, and severe fatigue.
Highly effective treatments for MS have been available for several years, but the most effective treatments, until now, have presented unacceptable side effects.
Tecfidera does not seem to cause life-threatening side effects. Even better, it is one of just three medications for MS that can be taken orally, no IVs required. And its mode of action is particularly on point for multiple sclerosis sufferers.
How Does Tecfidera Work?
Tecfidera acts as a particularly potent antioxidant. MS researchers have known for a long time that one of the ways the disease attacks the central nervous system is by the release of overly reactive free radicals of oxygen and nitrogen. These free radicals cause the release of hydrogen peroxide and peroxynitrite, which in turn damage the myelin coating of nerves in the brain, in the spinal column, and throughout the body.
The damage caused by this inflammatory process is usually not absolute. Neurons recover from inflammation, only to be attacked by free radicals all over again, causing a pattern of relapses and remissions that make tracking real progress in treating MS very difficult.
The way Tecfidera interrupts the free radical-driven process of inflammation that causes the symptoms of MS is by activating the nuclear 1 factor (erythroid-derived 2)–like 2 (Nrf2) antioxidant response pathway. This is one of the primary ways neurons protect themselves against the inflammation caused by free radicals.
How Well Does Tecfidera Work?
The BG-12 study group recruited over 1,200 people with relapsing-remitting multiple sclerosis, the variant of the disease in which symptoms periodically get better and periodically get worse, in 28 countries. MS patients in the study were aged 18 to 55. One-third of the volunteers for the study received a placebo, one-third received 240 mg of BG-12 twice a day, and one-third received 240 of BG-12 three times a day, for an average of 84 weeks. Neither the participants in the trial nor the researchers knew who was receiving the actual medication until the study was complete.
The study found that:
- Taking the medication twice a day reduced the risk of progressive disability by 38%. Taking the medication three times a day reduced the risk of progressing disability by 34%. (Twice a day was more effective than thrice a day.)
- Taking the medication twice a day reduced the risk of developing a brain lesion that could be detected with a brain scan by 90%. Taking the medication three times a day reduced the risk of developing a new brain lesion that could be detected by scan by 73%.
Tecfidera isn't a silver bullet for MS, but it definitely helps, and most commentators expect it to become a blockbuster, $3 billion a year drug. But is there a downside to using it? And if you need it, how can you afford it?