FDA approves Tecfidera/BG-12

[ru4cats]

I've posted this somewhere else, but I'll post again. I recently found out that the manufacturers "cost" of drugs is 10% of what they charge a hospital/infusion center/pharmacy/ and then the markup begins.... In the case of Tysabri in MT, the "cost" is $400, the hospitals pay $4000, and then the markup begins...One hospital charges over $17,000 per month for Ty. Research/development is only 1-3% of a company's budget. They are more than compensated for any new drugs. The patent runs until 2028, so they'll do well. That said, I am grateful for all new MS drugs that hit the market. However, I try to keep their "cost" in the back of my mind.

[jessiesmom]

A Doctor's Answers to Tecfidera/BG-12 Questions

I asked my dad (the M.D. who worked for the FDA) to address some of our concerns about Tecfidera:

1. The high dropout rate in the studies
2. Tumors in rats
3. Prescribing Tecfidera for people with pre-existing low white blood counts

Here are his answers:

1. The 30% drop out rate should be of no concern. In study 1, 69% on 240mg. b.i.d. and 69% on 240mg. t.i.d. dropped out, but 65% on placebo also dropped out. In study 2 the results were similar; 72%,70% and 64%. That is why you have placebo controls.

2. The tumors in rodents seem like a close call to me. In item 13.1 it is noted that the area under the curve at the highest dose not associated with tumors in rodents was similar to the highest recommended human dose (480mg./day). Close.


3. There is no specific prohibition in the "Prescribing Information" on giving the drug to those with pre-existing low lymphocyte counts, but in item 2.2 it instructs to identify those patients with pre-existing low lymphocyte counts, and that the drug has not been studied in such patients. It would be a brave doctor who put such a patient on the drug.

Hope this has been helpful.

[04blackcobra]

I made my neuro apt for 4-19-13 to discussed going from the gilenya to possibly BG-12.

[Alicious]

With #2, I'd be interested in knowing what the difference in body mass between an adult human and a rat means. Is it relevant?

Also, thank you for asking your father about this!

2. The tumors in rodents seem like a close call to me. In item 13.1 it is noted that the area under the curve at the highest dose not associated with tumors in rodents was similar to the highest recommended human dose (480mg./day). Close.

[rdmc]

Maybe somebody will answer this question for me. In the pdf that is the prescribing info, it clearly states that there was no difference in disability.

However, in a couple articles I've read, it says they did see improvement in disability.

So who do you trust? Also different numbers being batted about in different sources, some say 44% reduction in relapse, some list higher percentage reduction.

Is the pdf that was posted with prescribing info the final word...if so, where are these other numbers coming from.

[alanpgh]

Great Question rdmc!

I'm going to ask my Neuro, who is an MS Specialist with over 1200 MS patients.

Thanks,
Alan

[allHailye2]

rdmc - I noticed the same thing! It confused me because everywhere else says that it Does slow disability! The biogen website even says it slows it. So ?!?!

Alan - please let us know

[Marco]

Maybe somebody will answer this question for me. In the pdf that is the prescribing info, it clearly states that there was no difference in disability..

Please remember that Biogen was concurrently dosing 2 and 3 times/day. Some of the 3 doses/day statistics were better, but someone eventually settled on twice/day. This probably had to do with patients not complying with 3/dose/day scripts.

As for the EDSS scores. I believe the study you are citing was 12 weeks. Over that period of time there probably isn't much change in EDSS scores for any subset of patients without a flare. The 2 year study is where a significant difference was realized and that makes sense to me.

One of the research neurologists I met with said the BG-12 study participants had a better EDSS starting score than the Aubagio patients (meaning they had less disability to begin with). She believed that over time the BG12 numbers might dip and Aubagio numbers might rise.

[alanpgh]

Marco, thanks for the clarification!

Makes sense.

Alan

[rdmc]

Please remember that Biogen was concurrently dosing 2 and 3 times/day. Some of the 3 doses/day statistics were better, but someone eventually settled on twice/day. This probably had to do with patients not complying with 3/dose/day scripts.

As for the EDSS scores. I believe the study you are citing was 12 weeks. Over that period of time there probably isn't much change in EDSS scores for any subset of patients without a flare. The 2 year study is where a significant difference was realized and that makes sense to me.

One of the research neurologists I met with said the BG-12 study participants had a better EDSS starting score than the Aubagio patients (meaning they had less disability to begin with). She believed that over time the BG12 numbers might dip and Aubagio numbers might rise.

I was most interested in the difference between disability reports...and the PDF that jessiesmom posted seems to be the prescribing info for doctors ( her dad is a doctor and provided her the link...that is the document that says there was no slowing of disability.). the link is posted early in this thread.

[durgastiger]

TECFIDERA OR PROTANDIM

I GUESS MY BIGGEST QUESTION IS?

IS THERE A LEGAL BATTLE BETWEEN BIOGEN AND MAKERS OF PROTANDIM?

THERE SEEMS TO BE A LOT OF CHATTER AMONGST USERS OF PROBIOTICS, PROTANDIM AND OTHER HOMEOPATHIC ALTERNATIVES.

I HAVE BEEN DOING THE GAPS DIET FOR AWHILE, WITH HIGH KEFIR, FRUIT AND VEGGIE AND INCREASED MOVEMENT.

IS THERE TRUTH TO THE BREAK DOWN IN ENZYME PRODUCTION AND HEALTHY BACTERIA IN THE INTESTINAL TRACT AND STOMACH?

IT WORTH SEEING AN UPPER GI DOCTOR FOR.

[ColdInCO]

Renal Issues?

I told my Neuro i would go on BG-12 but am concerned about renal issues.

Does anyone know much about this? (other than what is in the PDF)

I have mild kidney disease so it does concern me. However so do the other MS meds... I suspect my kidney disease came from either Betaseron or Copaxone, just a hunch since they can't find other reasons for it.

Thank you!

I GUESS MY BIGGEST QUESTION IS?

IS THERE A LEGAL BATTLE BETWEEN BIOGEN AND MAKERS OF PROTANDIM?

THERE SEEMS TO BE A LOT OF CHATTER AMONGST USERS OF PROBIOTICS, PROTANDIM AND OTHER HOMEOPATHIC ALTERNATIVES.

I HAVE BEEN DOING THE GAPS DIET FOR AWHILE, WITH HIGH KEFIR, FRUIT AND VEGGIE AND INCREASED MOVEMENT.

IS THERE TRUTH TO THE BREAK DOWN IN ENZYME PRODUCTION AND HEALTHY BACTERIA IN THE INTESTINAL TRACT AND STOMACH?

IT WORTH SEEING AN UPPER GI DOCTOR FOR.

I'm not sure why you would think a multy level marketing company and a pharmaceutical company would be entering litigation over two entirely different products.

[durgastiger]

MULTI-FILING CLASS ACTION LAWSUIT

I'm not sure why you would think a multi-level marketing company and a pharmaceutical company would be entering litigation over two entirely different products.

JUST CHATTER I HAVE BEEN HEARING ON FACEBOOK. PRODUCERS OF PROBIOTICS, HERBAL REMEDIES AND PROTANDIM ARE SUING STATING THAT BIOGEN IS SELLING BG-12/TECFIDERA AS A PRESCRIPTION DRUG WHEN IT IS ALL BASED ON CURRENTLY USED KEFIR, PROBIOTIC, PROTANDIM HERBAL NATURAL REMEDIES.


JUST WHAT I AM HEARING. I WILL TAKE TECFIDERA ALONG WITH ALL THESE REMEDIES I AM ALREADY TAKING.

JUST CHATTER I HAVE BEEN HEARING ON FACEBOOK. PRODUCERS OF PROBIOTICS, HERBAL REMEDIES AND PROTANDIM ARE SUING STATING THAT BIOGEN IS SELLING BG-12/TECFIDERA AS A PRESCRIPTION DRUG WHEN IT IS ALL BASED ON CURRENTLY USED KEFIR, PROBIOTIC, PROTANDIM HERBAL NATURAL REMEDIES.


JUST WHAT I AM HEARING. I WILL TAKE TECFIDERA ALONG WITH ALL THESE REMEDIES I AM ALREADY TAKING.

Posting hearsay is not helpful or realivant. If I were you I would look at what Protandim is composed of and compare with what BG-12/Tecfidera is. As far as Protandim, It's benefits for MS have been well documented and available elswhere <curcumin> for much cheaper. This needs to be/and already has been discussed in the supliments forum, not here.