The fumaric acid ester BG-12: a new option in MS therapy.

In March 2013, BG-12 was approved by the US FDA and EMA for the treatment of relapsing-remitting multiple sclerosis (RRMS) after meeting the primary and most secondary end points in two global phase III trials (CONFIM and DEFINE). From these data, the optimal BG-12 dosage for the treatment of RRMS is 240 mg twice daily. In the DEFINE and CONFIRM trials, the relative reduction of annual relapse rates were 53 and 44% in the approval-relevant dosages, respectively. Moreover, in the DEFINE trial, progression of disability was significantly ameliorated with a relative risk reduction of 38%. In both studies, administration of BG-12 was generally well-tolerated and safe. Most common adverse events were flushing and gastrointestinal events, including diarrhea, nausea and upper abdominal pain, which were particularly common in the early phases of treatment. At present, the introduction of BG-12 into the European market and its position among current MS treatment regimens is awaited with great interest.