EU Approves Dimethyl Fumarate for First Line MS Treatment


Dimethyl Fumarate EU ApprovalDimethyl Fumarate was approved by the EU at the beginning of February 2014 as a first line treatment for multiple sclerosis. Known as the brand name TECFIDERA, which is marketed by Biogen Inc., this efficacious and novel treatment is specified for patients with the most common form of multiple sclerosis, relapsing-remitting multiple sclerosis, or RRMS. Dimethyl Fumarate is thought to work effectually by successfully activating the Nrf2 pathway, which in turn offers a viable pathway for cells in the body to defend themselves from both oxidative stress and inflammation from RRMS. The safety and tolerability of the Dimethyl Fumarate has been positive, as these hard capsules are designed to be gastro-resistant. The standard starting dose of Dimethyl Fumarate  is 120 milligrams, administered twice a day for seven days. After the initial full seven day week the patient is typically dosed with an increased amount of Dimethyl Fumarate , specifically 240 milligrams twice daily. Adverse side effects have been uncommon in study participants, as well as in aftermarket clinical data. Common negative effects from Dimethyl Fumarate include mild nausea, diarrhea, upper abdominal pain and flushing. Dimethyl Fumarate {TECFIDERA} has been the number one prescribed oral therapy for MS and RRMS in the United States since it’s FDA approval in March of 2013. This powerhouse therapy has also been approved in Canada and Australia since mid-2013.

myelin-sheathClinical trials of Dimethyl Fumarate {TECFIDERA} have proven to be palmy and operative for patients with both RRMS and MS in general. Not only does treatment with Dimethyl Fumarate aid patients in the reduction of relapses of debilitating symptoms, it also reduces the incidence of brain lesions and alleviates the overall progression of this devastating condition.  Encouraging and fruitful data from two large Phase 3 clinical studies of Dimethyl Fumarate  were the catalyst for the EU approval earlier this month. The duo of trials, coined CONFIRM and DEFINE also  encompassed an additional extension study deemed ENDORSE, which followed a number of patients with MS for almost six and a half years. In the study DEFINE patients received Dimethyl Fumarate twice daily according to the standard, best in care dosing schedule. Results from this patient population indicated significant reduction in the proportion of patients who relapsed by roughly 49 percent. The CONFIRM study also produced extremely encouraging results, showing that as compared to a placebo the patients who were dosed with Dimethyl Fumarate displayed greatly reduced relapse rates at the two year mark, and also offered a 21 percent reduction in disability progression at the 12 week point. Further data analyzed by researchers gleaned even more hopeful results, showing that in both of the aforementioned studies patients who were given  Dimethyl Fumarate  had sizable reductions in brain lesions, as compared to the placebo group.

LGM Pharma provides Dimethyl Fumarate, CAS# 624-49-7, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

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