BG-12: The New Normal For MS Treatment?

by Sara on August 25, 2012

BG-12BG-12 (Dimethyl Fumarate) has not yet been approved for use, but trials have been overwhelmingly positive for this low-risk oral drug. Approved for Fast Track (10 months of review) by the FDA on February 28 2012, BG-12 should be available to Relapsing-Remitting MS patients and possibly for individuals with rheumatoid arthritis as a pill taken 2 or 3 times daily before 2013. The European Union, Canada and Switzerland are also currently reviewing this drug.

In addition to rheumatoid arthritis, Dimethyl Fumarate (DMF) is also being studied for its effects on lupus and cancer. DMF is a Fumaric Acid Ester which has been used to treat psoriasis since 1959.

Neurologists around the world are already planning to make this their go-to first line treatment for patients with Multiple Sclerosis even though Biogen Idec (the company behind Avonex and Tysabri) has not yet released a price profile of the drug. Why is BG-12 expected to quickly become the world’s leading MS treatment?

The Good News

The good news is that compared to placebo, BG-12 seems quite effective. While data has varied from trial to trial, the latest data indicates that this treatment taken two times daily lowers relapses by 44% and by 51% when taken three times daily.

Specifically the various trials have provided the following averaged results:

Taken Twice Daily
53% annual reduction in relapse rate
44% relapse rate reduction at 24 months
21% reduction in disease progression
38% reduction in disability progression
85% reduction in the mean number of new or newly enlarging T2 hyperintense lesions
90% reduction in galadium enhancing lesions
72% reduction in T1 hypointense lesions

Taken Thrice Daily
48% annual reduction in relapse rate
51% relapse rate reduction at 24 months
24% reduction in disease progression
34% reduction in disability progression
74% reduction in the mean number of new or newly enlarging T2 hyperintense lesions
73% reduction in galadium enchanging lesions
63% reduction in T1 hypointense lesions

 

The Bad News

The bad news isn’t that bad. Death, vision problems, liver issues, and injection site reactions are not on this list. There are only some common side effects which seemed to lessen substantially after the first month of use:

  • flushing
  • nausea
  • diarrhea
  • abdominal pain
  • headache

What Does BG-12 Do?

BG-12 works as an immunomodulator with both cytoprotective and anti-inflammatory properties. Dimethyl Fumarate appears to have the potential to help normalize the immune response in many T-cell mediated autoimmune and inflammatory diseases.

It is believed that BG-12 will:

  • regulate the immune system by changing the immune response.
  • protect the blood brain barrier
  • enchance myelin repair
  • decrease central nervous system inflammation

 

Am I imagining things or is this the best risk/benefit ratio we’ve seen in Multiple Sclerosis treatment?

 

 

Do you hope to take BG-12 when it becomes available?

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{ 22 comments… read them below or add one }

michelle rucci November 20, 2012 at 10:28 PM

As soon as BG12 is available I would like to begin this new therapy.

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Sara November 21, 2012 at 7:26 AM

Michelle,

I can’t wait for this to become available either. Lately my liver enzymes have been climbing again on Gilenya and I want a safe oral alternative. I can’t tell you how many people are hoping to switch to BG-12 as soon as they can!

Good luck in starting this and please keep in touch if you do!

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Modi March 17, 2014 at 7:26 AM

sara it’s avilable now ,, did you try it? Is it better than G?

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michelle rucci November 23, 2012 at 7:22 PM

Yes!

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Robert Lawson December 2, 2012 at 3:15 AM

Interferon and Copaxone are not nice to my body. I look for ward to a therapy that doesn’t scare me as much as the disease. My nuero has already told me that I’ll be on it the day it is approved. :)

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Sara December 6, 2012 at 8:35 PM

You’re lucky to have a neurologist so willing to change your meds. The longer I have this disease the more stories I hear of doctors lying to patients just to avoid dealing with changing their medication. It’ll happen soon!

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Dave December 6, 2012 at 5:15 PM

I have been on the ABC drugs & I had a PML scare on Tusabri which I am still on since I grew allergic reactions to the others. I was told an October release of BG 12 but now that has been moved to February . It may cost more but I want to get on it since the alternative scares me. I am not afraid to die but getting PML is more devastating to everyone not including the person who has it. It may not be a cure but even though Thsabri helped me out the scare took years off my life. A drug with no know deadly side effects will give me the chance to live what life I have left

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Sara December 6, 2012 at 8:39 PM

PML really is frightening – it’s what has kept me from trying Tysabri for the past few years. Did you have PML or find out that you were positive for the virus?

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Robert Lawson December 6, 2012 at 6:40 PM

I agree. I tried Betaseron for almost 2 years until my thyroid shut off. It’s horrible, The panic attacks are terrifying to say the least.

Then I went on Copaxone. It took 1 and 1/2 months before the nuero took me off. The IPIRs were getting exponentially worse each time,

1st: day 3 – 10 min long and painful heart palpitations
2nd: day 30 roughly – 45 min full IPIR exprience
3rd: day 45 roughly – 5 hrs of full IPIR experience and blood pressure so high my blood vessles in eyes were popping out

My nuero said they were afraid to see what the next time would be like.

BG-12 has what??

flushing
nausea
diarrhea
abdominal pain
headache

Sounds like life. I’ll take it!!!

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Sara December 6, 2012 at 8:37 PM

Wow – it sounds like your reactions to these medications have been TERRIBLE. I see what you meant earlier! I’ve never heard of anyone having so many problems with Copaxone before!

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Cara December 19, 2012 at 1:53 PM

I, too, am anxiously awaiting BG-12. I was diagnosed on October 18, my birthday, and the pill review date was also extended this day for another 3 months. Can we say, not a great day in history. My doctor first stated this pill would first be out in January, but since the review was extended, he is now pushing the date March 2013. I am currently on Copazone, and while I have never had any terrible reactions to date, as it’s almost been two months, I still dread having to do the injection every day and would like to be able to just take a pill and feel my life is normal again. Not just a pill, but a pill that has been scientifically proven to be more effective than Copaxone and have less side effects. I pray daily for the approval process to be underway as I know there are many of us who want to be on this medication. This really tests our patience….

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Jessica Hinkel December 25, 2012 at 3:10 PM

Yes if I can. I can’t wait for this to become available.

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Kim January 11, 2013 at 4:20 PM

Yes I am hoping to begin it today! I am tired of shots.

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Sara January 11, 2013 at 9:40 PM

Kim, let us know what happens! Wishing you the best!!!

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carrie gash January 23, 2013 at 8:37 AM

Me too

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carrie gash January 23, 2013 at 8:35 AM

I can’t wait, I’m so excited

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Sue February 18, 2013 at 8:09 PM

I wish the FDA would hurry up! I’m tired of needles, and this medication looks like it is more effective without needles!!

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Dakota February 20, 2013 at 7:54 PM

16 years of shots has left bumps everywhere that I had the injection. I have been waiting for a pill even before the first one came out I kept asking my Neuro if there was going to be a pill out anytime and at that point he said no, he might have known but couldn’t tell anyone at that time. Going to start the BG-12 as soon as it comes out.

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Diana March 28, 2013 at 10:15 AM

I can’t wait either. Copaxone side effects have gotten so bad that I am always scared to take my shots. I read today that BG12 was approved. Don’t know if the site was right, but I sure hope so. Have appt. in April with nero, and she said that when it came out she was going to prescribe.

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Sara March 28, 2013 at 10:27 AM

I’m very excited about BG-12. I think that hypersensitivity is pretty common in MS (I have it) and shots just hurt like hell! It’s ironic that for so long the only medications to treat an illness for people who feel pain so strongly have been constant and painful injections.

This is the first MS treatment that I’m aware of that have had neurologists waiting for it to be available to prescribe. Normally, doctors will shy away from the new medications so that someone else’s patients can try them first. But it seems like many doctors are waiting on this with baited breath. Finally, a drug reported to be effective while also having a fantastic safety profile.

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Robert Lawson March 28, 2013 at 5:23 PM

Good news then. It was approved by the FDA 03/27/13. :)

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Robert Lawson April 1, 2013 at 5:17 PM

Awesome news. As of today, I saw my Neuro and will be the first patient on BG-12. :D

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