BG-12 news?

[Leeaura]

Saw my Neuro today. Seems I'm allergic to Gilenya and we needed to choose a new DMD.

Found out a couple of interesting things. First, he lurks here. I think that is sooooo cool that he would take the time to see what we are thinking! Second, insider info says that BG-12 will b approved around the end of April, and a flurry of things going on the first two weeks of May (brochures/samples hitting dr offices so med can get to patients ASAP). To back this up, he says that each time a company releases a new med, 6-8 doctors from each state are invited to a medical conference regarding the drug. He has already received his invitation for the conference which is scheduled for the last weekend in April. He has scheduled my next appt for May 14....says med should definitely be available to patients by then. Lets all keep our fingers crossed!

[JerryD]

The fact that your neurologist watches this site is 'very cool'. You are lucky that your doctor is a good advocate for you. We all need assistance like that. This BG-12 story has been promised for a long time. I hope it lives up to the hype. Good luck, fingers crossed !

[ggnutsc]

Better late than never

That's a little later than I had hoped to find... Rebif didn't work for me, so we were hoping to find something that would.

My Dr and I had hoped to start me on Ty in the next few weeks, but I found out today that I tested JC+. We agreed that BG-12 would be a good option.

He was hoping/thinking for it to become available a little sooner than May. In the meanwhile I will be on nothing. Sure hope they hurry it along!!!

[emily06]

That's good news

I'm glad to hear that about BG-12. Aubagio didn't work out for me. Guess my doctor didn't push hard enough for me to get that. BUT I was more interested in BG-12 anyway. So this will be a nice Birthday gift for me then!!

[ru4cats]

I sincerely hope you are correct that BG12 will be out soon. There have been so many up's and down's getting this drug out, I hope it lives up to the hype.

There were so many disappointments with the rush to Gileyna, I know there are many JC+ MSers waiting to switch to this drug. I'm JC-, so I'll continue with Ty since it's been good to me. Let's see where everyone is at in 2 years.

[Marco]

This is a wonderful example of why some drugs cost 1 billion to bring to market and why many drugs are so expensive.

When I wrote the BG-12 summary (http://www.msworld.org/forum/showthread.php?t=120682) the time period for approval I suggested was "between Q3 2012 and Q1 2013."

Prognisticators, including myself, use the "average" response and approval time for the FDA to suggest a date. There are more aspects like the potential for the drug, the number of drugs already serving the patients, etc. I personally thought 2012 would be a stretch considering it was an election year, and holy wars were going on over Obamacare and budgets.

Many of us fall somewhere between hopeful and desperate for bg-12 so we cleave to the earliest date given.

I'm not overally concerned about when it becomes available.
My real concern is what information was the FDA was requesting when the "delay" occurred. Was this simply pressure from Teva lobbyists and government red tape or was there actually a cause to pause and reflect.

BG-12 remains a potential game changer in our daily fight with MS, but the last thing we need is ANOTHER drug that is pulled or relabeled due to post-release health dangers.

[ru4cats]

Woops!

I was on another website this morning and found the following information from a facilitator:

"Hi all. I went to a lecture by Biogen , the makers of BG-12 last night....latest is that they will be applying for approval again in June of this year...they are saying it will at least be fall before they know if its accepted and probably the end of the year before its available for usage.

I spoke to the rep at length about clinical trials and how to get on it sooner- interestingly there are zero clinical trials available to get on. Alot of hush-hush around why this drug has yet to make it to market...

The Neurologist who spoke on the oral drugs stated that he is not using Gilenya or Aubagio at all in his practice as he has seen nothing good come from either of them - and in fact is seeing some very severe and unlisted side effects from Aubagio.... he also made mention that Gilenya is also facing reevaluation for safety and efficacy.

Looks like we are still going to be waiting awhile for Orals to be not only approved, but safe!

Looks like it might be a few months....

[JerryD]

thanks 'cats',
Your vigilance on this is much appreciated.
I was at a seminar for Copaxone, last night, and there was no mention of BG-12. I didn't expect to hear anything good about it. But there was nothing mentioned, at all. I hope this drug shows us something 'real' like some improvements in physical condition not just 'band-aid' mechanism.
Good luck

[TLC_31]

I was on another website this morning and found the following information from a facilitator...

I found that post on the other website. It was posted on February 8, and there has been zero collaborating information since. In the meantime, news reports earlier this week about a patent for Tecfidera (BG-12) routinely indicated the FDA will rule on it next month, which is in line with earlier reports.

I am puzzled why a Biogen rep would say they’re going to apply for approval in June … the company shouldn’t need to apply for approval, because the current application for Tecfidera is still live.

My theory is that the “facilitator” who authored that post, who is still calling Tecfidera by its earlier name, heard the Biogen rep talking about the company’s extended-release interferon and mixed up the two drugs. It would make more sense that Biogen would apply for approval of that interferon, known as Plegridy, in June.

[TLC_31]

EU authority issues positive opinion on Tecfidera

The Committee for Medicinal Products for Human Use has recommended the approval of Tecfidera as a first-line treatment do MS. The European Commission will decide in the second quarter whether to go ahead with marketing authorization.

The news release reasserts that such a decision is expected from the FDA within days.

http://www.biogenidec.com/PRESS_RELE...&ReqId=1799179

[Brenda Oregon]

BG-12 Tecfedera approved by EU

The EU has just announced that they have approved Tecfedera (BG-12) as a first line drug for MS.

I'm hoping the FDA follows suit quickly.

[ggnutsc]

I found this the other night when I was looking around for more details on the FDA and BG-12. If this is any indicator at all, the FDA has a date on their calendar for releasing an approval or rejection. The calendar suggests that that date is 3/28/13.

http://www.thestreet.com/stock-marke...ndar-2013.html

[durgastiger]

The EU has just announced that they have approved Tecfedera (BG-12) as a first line drug for MS.

I'm hoping the FDA follows suit quickly.

Is the FDA only American regulation? Separate from EU?

If so I'm ready to go to England and get BG-12 on the black market!

[TLC_31]

Is the FDA only American regulation? Separate from EU?

If so I'm ready to go to England and get BG-12 on the black market!

Don't get your plane ticket just yet. The post by "Brenda Oregon" isn't completely accurate; Tecfidera hasn't been completely approved in the EU yet. See my post just before hers. It's still a couple of months out in Europe.

In the U.S., the FDA is likely to rule on Tecfidera this week, and it has nothing to do with the EU, other than that they're presumably looking at the same information provided by Biogen. If it is approved by the FDA (and that's not a certainty), then it's on the U.S. market as soon as production, insurance, and a few other things are all in order.

Even then, remember that it's not a cure, and it does come with potential side effects.

[Alyms79]

I am wanting to know everything about BG-12.. I am on rebif now..but it is treating me badly!

So this might be my last ditch effort to stay stable...Right now..I am waiting to find out if my ms has switched from RRMS,to SPMS...

Neuro is very hopeful that when BG-12 is released by the FDA,that is will help me alot..

God I hope it is released soon!