Friday, 22 March 2013

BG12 given the thumbs up: 1st line oral DMT

Tecfidera (Dimethyl fumarate)

On 21 March 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tecfidera 120 mg and 240 mg, gastro-resistant hard capsules, intended for the treatment of adult patients with relapsing remitting multiple sclerosis. 

The applicant for this medicinal product is Biogen Idec Ltd. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.

The approved indication is: "treatment of adult patients with relapsing remitting multiple sclerosis".  The active substance of Tecfidera is dimethyl fumarate, a nervous system drug (N07XX09), that  primarily acts by triggering the activation of the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) transcriptional pathway. 

The benefits with Tecfidera are its ability to reduce the number of relapses in patients with relapsingremitting multiple sclerosis. The most common side effects are flushing and gastrointestinal events (e.g. diarrhoea, nausea and abdominal pain). 

A pharmacovigilance plan for Tecfidera will be implemented as part of the marketing authorisation. Treatment with Tecfidera should be initiated under the supervision of a physician experienced in the treatment of the disease.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.


The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-risk balance for Tecfidera and therefore recommends the granting of the marketing authorisation.


21 March 2013
EMA/167897/2013
Committee for Medicinal Products for Human Use (CHMP)



"A first-line license puts BG12 in pole position. I wonder if there will be any surprises around the corner; like a rare, but serious, adverse event? We now have to wait for NICE to deliberate."

CoI: multiple

11 comments:

  1. Now so much depends on how Biogen prices it. They spent a lot on the trials. But it is still a simple molecule and a high price will jar

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  2. Prof G, out of the three oral agenst: teriflunamide, BG12 and fingolimod, which do you think is the most effective and which do you think is the safest with the current available evidence?



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    1. BG12 and Fingolimod are more effective than Teriflunomide when it comes to a reduction in relapse rate. Fingolimod has a consistent effect on brain atrophy, it reduces the rate of brain atrophy which is a positive thing. In terms of safety the fact that Fingolimod was given a 2nd-line license in Europe tells you that it has more safety concerns. I personally think this is due to the legacy of the higher doses tested in the development programme. The way fingolimod is used in clinical practice makes it a lot safer. It is horses for courses; some people may respond to one and not the other. So it may be try one and see how you respond. If you respond well, i.e. no disease activity, then you stay on it. It is clear that we are now in the era of personalised medicine.

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  3. Thank you, prof G! Your response is most helpful!

    You are a champion for MSers and your team are heroes!

    Thank you, thank you, thank you!

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  4. Any idea how long NICE will take to consider these new orals? Weeks, months or years? Then I presume it will be upto individual PCTs to decide whether to fund them.

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    1. I recall the average approval time being ~14 months!

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  5. If one was willing to pay privately for this medication - i.e. not wanting to wait for NICE - is that now possible in the UK or are there still other steps to await?

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    1. Although the Committee for Medicinal Products for Human Use (CHMP) have given the thumbs up it takes another 2 months for the EMA to give Biogen-Idec their marketing authorization. So you have to wait until late May or early June for it to be available via private prescription.

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