BG-12 (Dimethyl Fumarate) has not yet been approved for use, but trials have been overwhelmingly positive for this low-risk oral drug. Approved for Fast Track (10 months of review) by the FDA on February 28 2012, BG-12 should be available to Relapsing-Remitting MS patients and possibly for individuals with rheumatoid arthritis as a pill taken 2 or 3 times daily before 2013. The European Union, Canada and Switzerland are also currently reviewing this drug.
In addition to rheumatoid arthritis, Dimethyl Fumarate (DMF) is also being studied for its effects on lupus and cancer. DMF is a Fumaric Acid Ester which has been used to treat psoriasis since 1959.
Neurologists around the world are already planning to make this their go-to first line treatment for patients with Multiple Sclerosis even though Biogen Idec (the company behind Avonex and Tysabri) has not yet released a price profile of the drug. Why is BG-12 expected to quickly become the world’s leading MS treatment?
The Good News
The good news is that compared to placebo, BG-12 seems quite effective. While data has varied from trial to trial, the latest data indicates that this treatment taken two times daily lowers relapses by 44% and by 51% when taken three times daily.
Specifically the various trials have provided the following averaged results:
Taken Twice Daily
53% annual reduction in relapse rate
44% relapse rate reduction at 24 months
21% reduction in disease progression
38% reduction in disability progression
85% reduction in the mean number of new or newly enlarging T2 hyperintense lesions
90% reduction in galadium enhancing lesions
72% reduction in T1 hypointense lesions
Taken Thrice Daily
48% annual reduction in relapse rate
51% relapse rate reduction at 24 months
24% reduction in disease progression
34% reduction in disability progression
74% reduction in the mean number of new or newly enlarging T2 hyperintense lesions
73% reduction in galadium enchanging lesions
63% reduction in T1 hypointense lesions
The Bad News
The bad news isn’t that bad. Death, vision problems, liver issues, and injection site reactions are not on this list. There are only some common side effects which seemed to lessen substantially after the first month of use:
- abdominal pain
What Does BG-12 Do?
BG-12 works as an immunomodulator with both cytoprotective and anti-inflammatory properties. Dimethyl Fumarate appears to have the potential to help normalize the immune response in many T-cell mediated autoimmune and inflammatory diseases.
It is believed that BG-12 will:
- regulate the immune system by changing the immune response.
- protect the blood brain barrier
- enchance myelin repair
- decrease central nervous system inflammation
Am I imagining things or is this the best risk/benefit ratio we’ve seen in Multiple Sclerosis treatment?
Do you hope to take BG-12 when it becomes available?