Tecfidera (BG-12) Coming to Europe


The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) determined that Tecfidera (BG-12) qualifies as a new active substance, extending Biogen’s patent protection on the drug and thus lifting the companies fears for drug development in Europe until at least 2024. 

So another orally active agent enters the armory, which can only be good news. More information once the EMA or ProfG posts it

Next issue for the Brits is PRICE and NICE

 I want to know will it work in PPMS/SPMS?
Does Active Get in the Brain in MS?

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  • How can it be a new substance? It's the main ingredient in Fumaderm which is sold in Germany for almost 20 years now. Surely the EMA can't overlook that?

    • I have posted on this recently; it is not quite the same substance as Fumaderm. Fumaderm is a mixture of MMF and DMF and BG12 is formulated differently. In addition, there is evidence that they may have different modes of action in side of the body.

    • I'm not saying Tecfidera is the same as Fumarderm, I'm saying Tecfidera which is DMF is one of the active substances in Fumaderm. So how exactly is it a new substance? Does making it in microcapsules as in Tecfidera qualify as a new active substance?

  • I have taken Alemtuzumab (fist year's dose) for my MS and am wondering about adding BG-12 to my treatment (leaving aside NICE etc for a moment) as a maintenance drug following the Alem 'induction'. Given it has a different mechanism of action and is not/minimally immunosuppresive, my layman's (non-data backed, I realise!) conclusion is that the added risks of combining these (over and above their individual risk profiles) are minimal and likely worth taking for the added potential benefit. I guess I am interested in your perspective on this and whether you think there will be neuros out there willing to treat the informated patient in this way? I realise there is no data and probably never will be, so it's about making the best, informed guess based on logic and an understanding of their respective mechanism of action, on which I'd welcome your views.

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