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Oral Drug Approved by the FDA


Friday March 29 2013 10:43 AM

TECFIDERA (BG-12) is approved in the US

The Food and Drugs Administration in the US has approved the licensing of Biogen Idec’s new oral therapy, Tefidera. Previously known as BG-12 the new therapy will be prescribed as a first line therapy for those with relapsing–remitting MS in the US. It is expected that the European Medicines Agency (EMA) will follow suit in due course, making the treatment available in Ireland.

Tefidera is taken orally twice a day. Common side effects include flushing, gastrointestinal upset, diarrhoea, nausea, abdominal pain, tiredness and headache. It is not fully understood how the drug works but it seems to help to reduce inflammation and protect the nerves.

Two significant trails have been completed to show the efficacy of the drug:

  • In the DEFINE trial the drug was compared with a placebo (dummy pill) and delivered in two daily doses and three daily does to 1,200 people with MS. Relapse rate reduced by 48% for the twice daily dose and 53% for the three times a day dose. Disability progression also reduced, 38% reduction for the twice daily doses and 34% for the three times a day dose.
  • In the CONFIRM trial the drug was compared with a placebo and glatiramer acetate  among 1232 people with MS. BG-12 reduced the number of relapses in one year by 44% for the twice-daily dose and by 51% for the three times daily dose, compared to placebo. In contrast, glatiramer acetate reduced the number of relapses by 29% compared to placebo. No reduction in disability progression was noted.

The review by the EMA may take a few months. If approved the drug may become the first oral first line therapy for people with relapsing-remitting MS.

Further information 

Author: MS Ireland

Tags: fda, emea, bg-12, tefidera


Duncan Pratt

Thursday April 25 2013 12:00

Do you have info on vitamin D3 supplement?


Sunday May 19 2013 13:06

has adate been set for the release date for bg12 in ireland? thanks aaron.

Multiple Sclerosis Ireland

Sunday May 19 2013 17:17

Hi Aaron,

There is no date set for the introduction of Tecfidera into Ireland. Although it has approval in Europe it still needs to g through the process here in Ireland. There is no timeline for this yet. We'll keep you up to date with developments. Sign up for eNews: http://goo.gl/3CNdq


Sunday April 06 2014 22:16

Hi, do we have a date set yet? will it be the summer time? thanks

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