Biogen files NDA for BG-12

Discuss Tecfidera (BG-12, dimethyl fumarate) as an oral treatment for multiple sclerosis.

Biogen files NDA for BG-12

Postby NHE » Thu Mar 15, 2012 3:40 am

Biogen files new drug application (NDA) for BG-12.

http://www.zacks.com/stock/news/70735/B ... alyst+Blog

Biogen Idec (BIIB) recently announced the submission of a new drug application (NDA) for its oral multiple sclerosis candidate, BG-12. The NDA was based on data from the phase III DEFINE and CONFIRM studies which showed that treatment with BG-12 led to a significant reduction in disease activity in multiple sclerosis patients. Moreover, the candidate had a favorable safety and tolerability profile.

Biogen will be filing for EU approval as well shortly. A response regarding the acceptance of the NDA should be out in a couple of months. We believe BG-12 could become a leader in the oral multiple sclerosis market once launched.
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Re: Biogen files NDA for BG-12

Postby ikulo » Wed Mar 21, 2012 7:27 pm

This one is going to be a blockbuster. I'm sure they're going to price it accordingly.
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Re: Biogen files NDA for BG-12

Postby NHE » Thu Mar 22, 2012 1:52 am

ikulo wrote:This one is going to be a blockbuster. I'm sure they're going to price it accordingly.


What I find disconcerting is that Biogen states that BG-12 achieves immunomodulation via glutathione depletion.


Fumarates improve psoriasis and multiple sclerosis by inducing type II dendritic cells.
J Exp Med. 2011 Oct 24;208(11):2291-303. Epub 2011 Oct 10.

    Fumarates improve multiple sclerosis (MS) and psoriasis, two diseases in which both IL-12 and IL-23 promote pathogenic T helper (Th) cell differentiation. However, both diseases show opposing responses to most established therapies. First, we show in humans that fumarate treatment induces IL-4-producing Th2 cells in vivo and generates type II dendritic cells (DCs) that produce IL-10 instead of IL-12 and IL-23. In mice, fumarates also generate type II DCs that induce IL-4-producing Th2 cells in vitro and in vivo and protect mice from experimental autoimmune encephalomyelitis. Type II DCs result from fumarate-induced glutathione (GSH) depletion, followed by increased hemoxygenase-1 (HO-1) expression and impaired STAT1 phosphorylation. Induced HO-1 is cleaved, whereupon the N-terminal fragment of HO-1 translocates into the nucleus and interacts with AP-1 and NF-κB sites of the IL-23p19 promoter. This interaction prevents IL-23p19 transcription without affecting IL-12p35, whereas STAT1 inactivation prevents IL-12p35 transcription without affecting IL-23p19. As a consequence, GSH depletion by small molecules such as fumarates induces type II DCs in mice and in humans that ameliorate inflammatory autoimmune diseases. This therapeutic approach improves Th1- and Th17-mediated autoimmune diseases such as psoriasis and MS by interfering with IL-12 and IL-23 production.
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Re: Biogen files NDA for BG-12

Postby DizzyDean » Sat Mar 24, 2012 3:48 pm

BG12 appears to be the second generation of a prior compound whose brand name is fumaderm. Fumaderm is approved in Germany to treat psoriasis but from what I've read - isn't generally used as first line therapy. It doesn't sound like fumaderm is particularly expensive in Germany - but its not the same compound as BG12.

On the topic of "will neuros prescribe it", and "will insurers pay for it", I found this:

http://decisionresources.com/News-and-E ... sis-112811
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Re: Biogen files NDA for BG-12

Postby NHE » Sun Mar 25, 2012 1:21 am

Some info on BG-12, dimethyl fumarate, from the MSRC.
http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1679


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Re: Biogen files NDA for BG-12

Postby 12321 » Sun May 13, 2012 6:07 pm

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Re: Biogen files NDA for BG-12

Postby jay123 » Mon May 14, 2012 8:13 am

DizzyDean wrote:BG12 appears to be the second generation of a prior compound whose brand name is fumaderm. Fumaderm is approved in Germany to treat psoriasis but from what I've read - isn't generally used as first line therapy. It doesn't sound like fumaderm is particularly expensive in Germany - but its not the same compound as BG12.

On the topic of "will neuros prescribe it", and "will insurers pay for it", I found this:

http://decisionresources.com/News-and-E ... sis-112811


With the money drug companies will be throwing at doctors of course they will prescribe it.
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Re: Biogen files NDA for BG-12

Postby CureOrBust » Tue May 15, 2012 5:41 am

jay123 wrote:With the money drug companies will be throwing at doctors of course they will prescribe it.
In Australia, I think the real question will be "will it be subsidised by the Govt?"

We have a system called PBS which subsidises expensive medications; such as MS DMD's. Recently, they approved Gilenya for subsidisation so it only costs $28 / month (as opposed to $2K+ / month); surprisingly fast. With one oral treatment approved for M.S. I am concerned that they may drag their heels on a second.
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Re: Biogen files NDA for BG-12

Postby gibbledygook » Fri May 18, 2012 8:47 am

I think this will get through the NHS in the UK quite quickly since its side effect profile seems significantly better than any of the other "new" drugs like Campath. I was quite surprised to hear my neurologist rule out emphatically either Campath or Gilyena because of their serious side effects. As for tysabri, forget about it! He is reassuringly conservative about treatments but sounded quite enthusiastic about BG12. I've asked another doctor to see if I can get it off label and to find out how much it would cost...
3 years antibiotics, 06/09 bilateral jug stents at C1, 05/11 ballooning of both jug valves, 07/12 stenting of renal vein, azygos & jug valve ballooning,
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