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Friday, October 25, 2013

BG-12: Sustained Efficacy, Safety Out to 4 Years in MS

COPENHAGEN, Denmark — Latest results from the clinical trial program with BG-12 (dimethyl fumarate; Tecfidera, Biogen Idec) suggest sustained clinical efficacy and safety in patients with multiple sclerosis (MS) taking the drug for up to 4 years.
In addition, a separate post hoc analysis of the phase 3 pivotal Determination of the Efficacy and Safety of Oral Fumarate in Relapsing–Remitting MS (DEFINE) and Comparator and an Oral Fumarate in Relapsing–Remitting Multiple Sclerosis (CONFIRM) clinical trials shows that BG-12 reduced relapses and disease activity in treatment-naive patients.
The latest long-term results come from the ENDORSE study, an extension phase of the DEFINE and CONFIRM trials.
Commenting on these results for Medscape Medical News, Bernd Kieseier, MD, Heinrich Heine University, Düsseldorf, Germany, who did a talk rounding up meeting highlights including these new results, said, "These are reassuringly meaningful clinical results showing that the effects of BG-12 over 2 years are maintained in the third and fourth year, with no additional safety concerns."
Ralf Gold, MD, St. Josef-Hospital/Ruhr-University in Bochum, Germany, a leading investigator in the extension study, said, "When making MS treatment decisions, we weigh efficacy and safety considerations, so it is encouraging to see that the positive profile of BG-12 observed in the DEFINE and CONFIRM studies has been maintained in the ENDORSE clinical trial to date."
These data were presented at the recent 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Newest Oral Therapy
BG-12 is one of the new oral therapies for multiple sclerosis. It was approved by the US Food and Drug Administration in the United States and is going through the reimbursement process in Australia and Canada.
In Europe, regulatory authorities are still reviewing the drug, with "data exclusivity" discussions ongoing. Biogen told Medscape Medical News that it has strong patent protection for the product, but the company is in discussions with the European authorities on regulatory data protection "to ensure maximum coverage is in place."


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