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BG-12 (dimethyl fumarate, Tecfidera) - factsheet

Date of issue: April 2014
This factsheet will be reviewed within three years

Contents

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Overview

Drug in development
BG-12 Appraisal stage
Other names Tecfidera, dimethyl fumarate
What is it? BG-12 is an oral drug treatment for relapsing remitting multiple sclerosis
  • BG-12 is taken as a tablet, two times daily.
  • BG-12 reduces inflammation caused by the MS immune response and protects nerves against injury.
  • In phase III studies, people taking BG-12 had about half the number of relapses as people taking placebo (dummy pill).
  • The most common side effects have been:
    • flushing and feeling hot
    • gastrointestinal upset - diarrhoea, nausea, abdominal pain
    • headache
  • BG-12 was granted a licence by the European Medicines Agency in February 2014. In April 2014, the Scottish Medicines Consortium approved the use of BG-12 for the NHS in Scotland. NICE (National Institute for Health and Care Excellence) is currently appraising BG-12 to determine whether the cost of treatment is approved for the NHS in England and Wales.

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How does it work?

In multiple sclerosis, the immune system mistakenly attacks the myelin sheath that surrounds nerve cells in the brain and spinal cord. The damage disrupts the way in which messages, or nerve impulses, are carried to and from the brain, leading to a variety of symptoms.

BG-12's mechanism of action is not fully understood, but laboratory studies suggest that it may work in two ways1:

  • reduces the inflammation caused when the immune system attacks myelin, resulting in less damage to myelin.
  • protects nerve cells from damage caused by chemicals released during the immune attack.

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How is it taken?

BG-12 is taken as a tablet, two times per day.


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What are the results so far?

Two phase III trials found BG-12 effective at reducing the number of relapses to approximately half of that seen in those taking placebo (dummy pill). In one study (DEFINE) the progression of disability was reduced for people taking BG-12; this effect was not seen in the second study (COMFIRM).

  • DEFINE2 - BG-12 compared to placebo
    This two year study compared BG-12 taken either two or three times daily and placebo in more than 1200 participants with relapsing remitting MS. Compared to placebo, the drug reduced the number of relapses in one year by 53% for the twice daily dosing and 48% for the three times a day dosing.

    BG-12 twice daily reduced the risk of disability progression by 38% while BG-12 three times per day reduced this risk by 34%.
  • CONFIRM3 - BG-12 or glatiramer acetate compared to placebo
    This two year study with 1232 participants was similar to DEFINE, but with an additional group who took glatiramer acetate (Copaxone) for comparison.

    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.

    The reduction in disability progression observed in the DEFINE study was not seen in the CONFIRM study.

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Side effects

The most common side effects were:

  • flushing and feeling hot
  • gastrointestinal upset - diarrhoea, nausea, abdominal pain
  • headache

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What further studies are planned?

No further clinical trials are currently underway.


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Licensing and appraisal

BG-12 was granted a licence by the EMA (European Medicines Agency) in February 2014.

In April 2014, the SMC (Scottish Medicines Consortium) approved the use of BG-12 for the NHS in Scotland.

NICE (National Institute for Health and Care Excellence) is currently appraising BG-12. This will determine whether the cost of treatment with BG-12 is approved for the NHS in England and Wales. A decision is expected mid 2014.


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References

  1. Scannevin RH, et al.
    Fumarates promote cytoprotection of central nervous system cells against oxidative stress via the nuclear factor (erythroid-derived 2)-like 2 pathway.
    Journal of Pharmacology and Experimental Therapeutics 2012;341:274-84.
    abstract
  2. Gold R, et al.
    Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis.
    New England Journal of Medicine 2012;367:1098-107.
    abstract
  3. Fox RJ, et al.
    Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis.
    New England Journal of Medicine 2012;367:1087-97.
    abstract

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Drug development process explained

Phase I
Phase 1
The first step in testing a new drug is to determine the safety of single doses in a small number of healthy volunteers. This stage helps researchers understand some aspects of how it works and establishes the likely dose required.


Phase II
Phase 2
If the treatment proves to be safe, studies begin to determine the effectiveness of the drug in people with the condition to be treated. These studies may last several months or years and involve larger numbers of people, perhaps one or two hundred. The study will generally be

  • controlled - the drug is compared with the standard treatment or placebo (dummy treatment)
  • double-blind - neither the investigators nor the participants know which treatment they are receiving, and
  • randomised - participants will be randomly allocated to receive active treatment or placebo.

Phase III
Phase 3
If a drug shows effectiveness, a larger study is conducted in hundreds of people. These clinical trials may be conducted at different locations (multi-centre) and across several countries and may last several years. These studies allow researchers to more accurately assess the potential of the new drug in a wider range of people and compare it to existing treatments


Licensing
Licensing stage
Data from all of these phases is presented to the regulatory authorities (in the UK this is the MHRA - Medicines and Healthcare products Regulatory Agency or the EMA - European Medicines Agency). If the authorities are satisfied that the new medicine is effective, safe and meets manufacturing quality standards, a marketing authorisation or licence is issued.


NHS appraisal
NHS appraisal stage
Once a new medicine has been licensed, there may still be one final hurdle. Set up in 1999 to help eliminate postcode lottery prescribing in England and Wales, NICE (National Institute for Health and Clinical Excellence) appraises certain new medicines and looks at issues such as cost effectiveness of the new treatment. In Scotland, appraisal is carried out by the SMC (Scottish Medicines Consortium).

The NHS is legally obliged to fund medicines recommended by NICE or SMC. If NICE or SMC do not approve a new medicine, then local health authorities are not required to provide funding for it.


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