BG12 finally gets its EU marketing authorisation

At long last the BG12 capsule has landed in Europe; how long will NICE take to green light it? #MSBlog #MSResearch

“At long last BG12 or dimethyl fumarate (Tecfidera) has been given its European marketing authorization. BG12 is the third oral MS drug to come to market in Europe. Cladribine and Laqunimod, been the other two of the five, who have not made it; yet?”

“When will it be available in the UK? This will depend in it being given a green light by NICE. I assume NICE will be extracting a major discount for the NHS;  the rumour is that it will be in the order of a third of the price of what it costs in the US.”

“There has been a lot of discussion on BG12 on  this blog with regard to its efficacy, safety and mode of action. As soon as we get a green light on its availability in the UK I will do a lengthy Clinic Speak post on how we see it working.”

Other posts of  interest:
15 Nov 2013
Objective: Currently, direct comparative evidence or head-to-head data between BG-12 (dimethyl fumarate) and other disease-modifying treatments (DMTs) is limited. This study is a systematic review and data synthesis of 
23 Nov 2013
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 
25 Oct 2013
“Dimethyl-fumarate, DMF or BG12 is an effective DMT. It is given orally as a twice a day dose. One of the main side effects of the drug is facial flushing that comes on shortly after taking the tablet and subsides within 4-6 weeks.
11 Oct 2013
These data suggest that the modulation of the BBB is not a major mechanism of action of FAE in inflammatory demyelinating diseases of the CNS. Does BG-12 work? how does it work? Well the trial data is clear it works and 
12 Jul 2013
Background: In the double-blind, placebo-controlled, Phase 3 DEFINE study in patients with relapsing-remitting multiple sclerosis, oral BG-12 (dimethyl fumarate) significantly reduced the proportion of patients relapsed 
18 Jun 2013
Objectives & Methods: To investigate the clinical efficacy of BG-12 240 mg twice daily (BID) and three times daily (TID) in MSer subgroups stratified according to baseline demographic and disease characteristics including 
11 Jun 2013
Objectives: In Phase 3 clinical trials, BG-12 (dimethyl fumarate) demonstrated consistent clinical and radiological efficacy across a broad range of RRMSer. Here we evaluate the impact of BG-12 on the clinical efficacy in the 
17 Apr 2013
“Some of you may have have already clicked through the link (DMF DIY), that was posted yesterday on the blog, in a comment, and read the DIY instructions on how to formulate your own version of dimethyl fumarate or BG12 
31 Mar 2013
BG12 will cost $54,900 annually. Robert Weisman. Biogen Idec’s new pill to treat MS will cost about $54,900 per patient annually. Biogen Idec Inc. said Friday it will price Tecfidera, its newly approved pill to treat 
03 Apr 2013
OBJECTIVE: To characterize the temporal profile of BG-12 (dimethyl fumarate) treatment efficacy in an integrated analysis of data from the Phase 3 DEFINE and CONFIRM studies. BACKGROUND: Oral dimethyl fumarate has 
03 Jun 2013
Biogen Idec delays BG12 launch in Europe. PMLive. Biogen Idec says Tecfidera launch delayed in Europe. 31 May 2013 MSers in Europe who are eager to start Biogen Idec’s new oral treatment Dimethyl Fumarate 
19 Apr 2013
$60,000 is outrageous. There is a risk in making DIY bg-12 but every day is a risk with MS. Overdoing normal activities is a risk. The link also showed where to buy pharmaceutical grade DMF. I’d be concerned more about the 
30 May 2013
“My poster from the ISPOR 18th Annual International Meeting in New Orleans. The main finding is that BG12 or DMF reduces the proportion of relapses needing to be treated with intravenous steroids. Use of steroids is a 
31 May 2013
DMF or BG12 launch in US defies analysts predictions. Matthew Herper. Biogen Idec’s MS Drug Launch Is Going Amazingly Well. These Two Graphs Prove It. PHARMA & HEALTHCARE . 5/29/2013 @ 11:16AM Sales of the 
21 Mar 2013
“My first poster today at the AAN. The data speaks for itself. Treatment with BG12 reduces the need for steroids and hospitalizations. This data supports health economic arguments for BG12.” 
25 Jan 2012
There is a new oral drug called BG12 that has been found to be effective at inhibiting relapses (reduction of around 50%) in MSers in the phase III studies, but the question is whether it does other things that may be beneficial 
22 Mar 2013
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.
20 Mar 2013
“Biogen-Idec have been given patent protection for BG12 until 2028. Patents are the bread and butter of the pharma industry; they allow Pharma to make money and re-invest in new drugs. Without patents innovation would 
02 Sep 2011
Results: BG-12 240 mg three times daily significantly reduced the number of new Gd+ lesions compared with placebo in the following subgroups: EDSS score ≤ 2.5 (74%), EDSS score > 2.5 (63%), no Gd+ lesions at baseline 
02 Oct 2012
There is an expectation that the new drug BG-12 is going to be good news and we know about the results of the phase III trials. This will feature heavily at ECTRIMS next week as the results of the CONFIRM and DEFINE trials 

CoI: multiple

About the author

Prof G

Professor of Neurology, Barts & The London. MS & Preventive Neurology thinker, blogger, runner, vegetable gardener, husband, father, cook and wine & food lover.


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