Oral MS drug treatment undergoes marketing approval process

BG-12 (also know as dimethyl fumarate) a new experimental oral drug therapy for the treatment of relapsing remitting MS (RRMS), is being reviewed for approval by the Food and Drug Administration (FDA) and the European Medicine’s Agency (EMA). Both applications were submitted in the spring of this year. It is anticipated that the application will meet with approval in early 2013.

As an oral drug therapy, taken either twice or three times day, with a strong safety record, it is hoped that BG-12 will be a first line therapy for RRMS, providing an easier method of administration than conventional MS drug treatments. It is thought that BG-12 acts as an anti-inflammatory working by protecting nerves against injury.

The application was based on BG-12’s research and development programme, in which BG-12 demonstrated reductions in MS disease activity.

  •  In the CONFIRM clinical trial, which had over 1400 participants, BG-12 reduced the annual relapse rate by 44% when taken twice a day and by 51% when taken three times a day. In comparison, Copaxone (a current injectable therapy) reduced the annual relapse rate by 29% (when compared to the control group).

  • The most common side effects were flushing and feeling hot, gastrointestinal upset, diarrhoea, nausea, abdominal pain, tiredness and headache. No serious side effects specific to BG-12 have been reported from clinical trials.

Doug Williams, Biogen's executive vice president of research and development, in an interview said “The safety profile has continued to hold up nicely from one study to the next,". He believes BG-12 "should be front-line therapy for patients" based on the risk-benefit profile seen in BG-12 clinical trials.

Biogen Idec already makes multiple sclerosis drugs Avonex and Tysabri, which are given by injection and infusion, respectively.

MS Ireland hopes that market approval will be achieved by early next year. We look forward to the advent of oral based therapies for people living with multiple sclerosis. For further information, read our new BG-12 information sheet. 

Further reading: links on BG-12:

CONFIRM Clinical Trial April 2012 Press Release

CONFIRM Clinical Trial October 2011 Press Release

DEFINE Clinical Trial October 2011 Press Release