Abstract
BG-12 was recently approved in the USA, Canada and Australia as an oral treatment for relapsing–remitting multiple sclerosis after positive results from two large pivotal Phase III studies. Approval is also imminent in the EU, where BG-12 has received a positive opinion from the European Medicines Agency Committee for Medicinal Products for Human Use in March 2013. The active ingredient, dimethyl fumarate, is thought to act mainly by inducing NF-E2 p45-related factor, thereby reducing oxidative stress, which is considered to be one of the pathogenic mechanisms in multiple sclerosis. The agent is not only highly effective at reducing relapse rate but also appears to slow disability progression across a wide variety of patient groups. With the oral route of administration and a good safety profile, BG-12 will likely become a valuable treatment option for multiple sclerosis patients and neurologists.
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