Drugs Xagena
Dimethyl fumarate ( BG-12, Tecfidera ) is a new oral drug approved by FDA ( Food and Drug Administration ) and EMA ( European Medicines Agency ) for relapsing-remitting multiple sclerosis ( RRMS ).
The drug was much anticipated because of its possible superiority over currently available medications: Fingolimod and Teriflunomide as the only multiple sclerosis treatments currently available in oral form.
A systematic review with meta-analysis has assessed the efficacy and safety of Dimethyl fumarate in the treatment of relapsing-remitting multiple sclerosis.
Two trials, DEFINE and CONFIRM involved 2,651 patients and compared Dimethyl fumarate taken either two or three times daily with placebo in patients with relapsing-remitting multiple sclerosis.
Additionally in CONFIRM trial third group of patients received Glatiramer acetate.
The overall results of the meta-analysis showed that Dimethyl fumarate ( at both dosages ) given to patients with relapsing-remitting multiple sclerosis is safe and statistically significantly more effective than placebo in reducing the proportion of patients who had a relapse by 2 years, the rate of disability progression and the mean number of Gadolinium-enhancing lesions at 2 years.
The comparison between Dimethyl fumarate and Glatiramer acetate has revealed that the analyzed agent could potentially be more effective in the treatment of relapsing-remitting multiple sclerosis.
In conclusions, despite limited RCTs ( randomized controlled trials ) data available, both analyzed Dimethyl fumarate regimens have shown their efficacy on clinical disease parameters and other measures of disease activity in relapsing-remitting multiple sclerosis.
The safety profile of the study agent was acceptable. ( Xagena )
Kawalec P et al, Curr Neuropharmacol 2014;12:256-268
XagenaMedicine_2014
