« Back

Oral Drug Approved by the FDA

Fitted

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

Comments

Duncan Pratt

Thursday April 25 2013 12:00

Do you have info on vitamin D3 supplement?

Aaron

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

Aaron

Sunday April 06 2014 22:16

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

Add a comment

Your email address will not be published and will only be used by MS Ireland to contact you should there be an issue with your comment.

Please read our policy on making comments. Basically, respect other people’s view, use appropriate language and be nice! Comments are published between 9am and 5pm, Monday to Friday.

We ask this question to ensure that you are a real person, and not a computer adding information automatically.

By commenting, you are adhering to our Terms of use / Privacy

Latest News

More news

What's hot

Small_camera-photographer-yellow-photography

Enter our 2020 Calendar Competition!

Calling all budding photographers! Enter our competition to see YOUR photo in our new calendar!

Find out more

Events Calendar

» Our next Event

21 June 2019: Weekly Physiotherapy classes for people with MS, starts 11th January (ongoing classes throughout 2019 please check...

View all events

eNEWS SIGNUP

If you'd like to receive e-news updates from The Society please enter your email address below. If you want to know more about how we manage personal data then please see our privacy policy.

My local MSI

Map of MS Ireland's service areas South Mid West West Midlands South East North East North West North Dublin City and Fingal South West Dublin and Kildare South East Dublin and Wicklow