BG-12 Summary

[bkehr]

BG-12

I met with my neurologist today, and he said it's looking as though BG-12 should be available *hopefully* sometime in the Spring of 2013. The more I learn about it, the more positive I feel about it. The side effects don't seem as severe as those I still experience with Betaseron. Plus, NO SHOT! That's a biggie, as I've gotten necrosis in the legs, so no longer use that site, the backs of my arms get huge red, hot blotches that last for weeks, and my stomach has become too sensitive to give the injections there anymore.
Medicare usually seems to drag when a new medication comes out, so hopefully they won't be too long approving this one.
I'm excited to learn more about BG-12, and interested to hear any positives/negatives anyone may have to share. Thanks!

[Ryluria]

My neuro was telling me about 2 pill forms, one that was already approved and one that was under approval. Could this be the one he was talking about?
He knows about my plans to get pregnant and he said that this one would be safe to take while pregnant, but the other one you cannot get pregnant for 2 years after taking.
If this is the one that is safe to take while pregnant I definitely need to do some more research. I'd definitely like to get off injections anway!

[Alicious]

I don't know if BG-12 is safe during pregnancy, but Aubagio, the pill newly on the market, is pregnancy class X. Basically, they know it causes serious issues with fetal development, so to get it prescribed I had to take a blood pregnancy test and my neuro discussed my birth control methods in detail. Heck, even men are advised not to try to impregnate their partners while on it. It's a big deal.

Now, while it can stay in your body for 8 months to 2 years (it stays in the bile), it can be cleaned out rapidly (11 days ish) with other, non harmful medications--they stuff they used to treat cholesterol before statins, per my neuro. Apparently those meds are annoying, but safe and doable. So, you can go on it if you want to get pregnant in the next few years, but you have to get off of it with the help of a doctor to clean it all out.

Long story short: the one on the market is a bad plan if you want to get pregnant soon; even though you can get it cleaned out of your body to levels they think are fine, it's still a big hassle if there are other meds on the market you can use. If I were you, I'd stay on your injections until BG-12 hits the market. I know I plan to switch to it pretty much the second I can.

[Ryluria]

Thanks for the info. I wouldn't take it while I knew I was pregnant, but he said it would be safe if I became pregnant while I was on it. He was pretty mad at me for stopping the Betaseron for a few months while I was trying (oops!). No results in the pregnancy department so I went back on it a few weeks ago. Sick of the blotches and bruises already...

[Alicious]

Aubagio isn't safe at all to become pregnant on; I wonder if he meant another med? This one is associated with serious fetal malformations, and it has a black box warning to that effect.

http://www.fda.gov/NewsEvents/Newsro.../ucm319277.htm

"Also included in the Boxed Warning is an alert noting that, based on animal studies, the drug may cause fetal harm. For this reason, Aubagio is labeled as Pregnancy Category X, which means women of childbearing age must have a negative pregnancy test before starting the drug and use effective birth control during treatment."

[KateA2]

I had my 6 month MS-Neuro check up (everything looks the same/A-OK for now, yay!) but we discussed my current Copaxone regime, and BG-12 coming on the market in March 2013. She said the data looks quite promising for BG-12, but that I seem to be doing A-OK on Copaxone...so it's up to me if I want to stay or "go"

My neuro feels the new drug should be stocked/set-up for payment through insurance in mid-March. So I'm going to make the switch in April (after the doc takes another looksee and makes-sure I'm doing well.)

I'm all for no-more-shots and less-chance of Eville Relapses and some protection from Ultra-Eville Progression. I already take pills 3x a day, adding a few tabs to what I already take would be easy-peasy.

[ChocolateChip]

I was curious if anyone has any previous knowledge of how long it takes after FDA approval for a medication to hit the market? Given the 3 month extension on BG12 bringing the final time span to March 28, I'm curious to how long it would take to get out to the public, once FDA gives the ok. I would assume Biogen has the production button ready to push.

Also, from my understanding every healthcare inc. has its own methods of getting it in their system and approving it themselves. So if you know of any info on specific hmo/healthcare/etc general quickness of getting new meds internally approved would also be greatly appreciated.

Thanks for all info and effort. And best holiday wishes to all.

[hope32]

Thanks so much for the summary! I just had my yearly checkup with my MS specialist. I've been on Copaxone in the past and now Betaseron for several years and I've been SO eager for a good oral MS drug to come out. My doctor told me about Aubagio and BG12 today and I'm really excited about BG12! He encouraged me to research both and I'm supposed to go back in 6 months for a baseline MRI and then switch to one or the other. BG12 sounds so promising, I'm so excited and SO ready to be done with shots!

[kinnarde]

BG-12 Next Week

I start BG-12 next week.... Or rather I start the process. I am currently on Copaxone and I am OVER IT. Will update next week.

[rickalex2]

BG-12

Your starting the process to take BG-12?!! REALLY??!! How are you able to do that, I heard it hasn't been approved yet and actually there's been a stall in its approval. I used to take Avonex, then went to Tysabri for the last 4 years, but now I am JCV positive and because I've been on it so long, I just can't take the chance to take it anymore! I need to start something soon and was waiting for BG-12 to become available. Whats the story that your able to get it?

[MS TOO]

Count me as another watching closely for when BG-12 is approved by the FDA for use. I've been on Copaxone for
7 1/2 years and last month my neuro gave me the news that I am now officially secondary progressive with my latest MRI showing some active inflamation of the lesion on my spine that is making me walk poorly and my left side weak.

He explained the drug options to me and none of them sounded like they would be easy to transition to so I asked him if I could stay on Copaxone until BG-12 was approved and then make the switch. He agreed with this approach so I am now waiting impatiently. Hearing about TEVA Neuroscience trying to slow approval of it is frustrating!

[Myoak]

For more about Teva slowing down Biogen getting FDA approval for BG-12 here is a link, if no one has posted it:

http://www.globes.co.il/serveen/glob...did=1000813353

[Shiranova2003]

How?!?!?

I start BG-12 next week.... Or rather I start the process. I am currently on Copaxone and I am OVER IT. Will update next week.

My neuro wants to wait until it is approved by FDA. Please let me know, as I would rather not wait until March/April/May.

[bree2013]

Is it still going well?

My neurologist sent an Rx and "letter of compassionate use" to Komtur Pharmaceuticals in Germany. They make Fumaderm, which is essentially BG-12 (fumaric acid) which has been used for autoimmune psoriasis in germany for 20 years safely. Komtur shipped the drug as soon as they received payment, which is about $600/month; the FDA held it at the border for two days until they received my doctor's letter documenting that we had used all possible US approved meds. FedEx delivered it next day. I've been taking it 8 weeks, gradually increasing dose. No side effects except mild flatulence. No disease progression or improvement yet, but it's early. I'm quite hopeful. Cost an issue but it's only until BG-12 approved in US, I figure.

Ellen Case,

Just curious if you're still taking BG-12 and if things are still going well? Are side effects the same? Do you notice improvement?

I do hope it is working out for you. Any current info would be greatly appreciated.

Bree

[pballer76]

bg-12 release date

I read on:
thestreet.com drug-approval-decision-calendar
that March 28, 2013 is the day for news on BG-12.

I cant wait!