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FDA approves Tecfidera/BG-12

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  • alanpgh
    replied
    Great Question rdmc!

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

    Thanks,
    Alan

    Leave a comment:


  • rdmc
    replied
    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.

    Leave a comment:


  • Alicious
    replied
    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!


    Originally posted by jessiesmom View Post
    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.

    Leave a comment:


  • 04blackcobra
    replied
    I made my neuro apt for 4-19-13 to discussed going from the gilenya to possibly BG-12.

    Leave a comment:


  • jessiesmom
    replied
    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.

    Leave a comment:


  • ru4cats
    replied
    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.

    Leave a comment:


  • emily06
    replied
    BG-12

    I asked my neuro when I could get BG-12 and he said it cannot be prescribed yet. Something about having to wait until after the big launch meeting which would be after May 6.
    But since I'm having those back and neck pains, I think I'm going to make an appt with my neuro soon (before the Launch Meeting).
    I'll let you know what I hear.

    Leave a comment:


  • rdmc
    replied
    Originally posted by KateA2 View Post
    I read on a business article that the yearly price proposed by Biogen is $50,000 (US) per year. Not sure about pricing elsewhere, and there will likely be bigger-insurance bargaining...but that's $4100 a month. Yowza!

    My copaxone 'script is $3200/month, I pay $15 copay *phew*
    $4100 per month for 60 pills (about $68 bucks a pill.) Well I understand you're not paying for the "pill" you're paying for the research and testing, but this was already an established treatment in Europe for psoriasis.

    I don't know, I thought that because the others injectibles include so much more than just the med, i.e. syringe, special packaging, etc. This might be a little lower, but then it is the latest and greatest, and they always charge more.

    Wonder if insurance will make the doc prove you've failed on another DMD therapy before letting a patient use BG12. As you said, those with group insurance, will probably have to go through a special pharmacy and the insurance company will make a deal for a better price. For drugs like this, I bet it ends up on non-formulary list...our copay is 3 times what it is for regular drugs, but still not bad. I imagine they'll have an assistance program for those without insurance.

    Time will tell.

    Leave a comment:


  • KateA2
    replied
    I read on a business article that the yearly price proposed by Biogen is $50,000 (US) per year. Not sure about pricing elsewhere, and there will likely be bigger-insurance bargaining...but that's $4100 a month. Yowza!

    My copaxone 'script is $3200/month, I pay $15 copay *phew*

    Leave a comment:


  • rdmc
    replied
    [QUOTE=brainless;1405623]
    Originally posted by jessiesmom View Post


    What about the tumors in the rats?
    Looks like the tumors and leiomyosarcoma was seen in dosages higher than the dosage they recomend (if I'm reading it right.)

    This part was interesting to me: "The median age was 37 years,median time since diagnosis was 3 years, and median EDSS score at baseline was 2.5. The median time on study drug for all treatment arms was 96 weeks. The percentages of patients who completed 96 weeks on study drug per treatment group were 72% for patients assigned to TECFIDERA240 mg twice a day...TECFIDERA had a statistically significant effect on the relapse and MRI endpoints described above. There was no statistically significant effect on disability progression. "

    So the study was for those who were relatively early in their diagnosis, and had a low EDSS score...and as with the latest info after studying Betaseron for years, there is no significant effect on disability progression.

    Add to that my recent understanding of MRIs showing a brain that is in a constant rate of changing lesions and I guess I'm a little jaded: http://www.msdiscovery.org/news/news...more-meets-eye

    That's a little disappointing, also wondering if side effects are mild, why did 30% drop out of the study.

    I'm going to try it and see what happens. Wonder what the cost of a month's worth of the normal dosage will be. They hadn't set up the cost yet (from what I read in another article.) We know what Avonex and Tysabri (their other products) cost. I can't imagine this will be less, but at the same time can't see how a bottle of 60 pills (the maintenance dose) could cost $3,000...that'd be 50 bucks a pill...time will tell.

    Well, I'll be in line with everyone else giving it a chance and hoping for the bet.

    Leave a comment:


  • brainless
    replied
    [QUOTE=jessiesmom;1405471]My dad is an M.D. who worked for the FDA for many years. He sent me a link with the full prescribing information for this drug. I have high hopes for it as I know many others do also.



    What about the tumors in the rats?

    Leave a comment:


  • jessiesmom
    replied
    Reduced White Blood Cell Count

    This is the portion of the Full Prescribing Information that deals specifically with the reduction of lymphocytes after taking Tecfidera/BG-12:

    5.1 Lymphopenia

    TECFIDERA may decrease lymphocyte counts [see Adverse Reactions (6.1)]. In the MS placebo controlled trials, mean lymphocyte counts decreased by approximately 30% during the first year of treatment with TECFIDERA and then remained stable. Four weeks
    after stopping TECFIDERA, mean lymphocyte counts increased but did not return to baseline. Six percent (6%) of TECFIDERA patients and <1% of placebo patients experienced lymphocyte counts <0.5x109/L (lower limit of normal 0.91x109/L). The incidence of
    infections (60% vs 58%) and serious infections (2% vs 2%) was similar in patients treated with TECFIDERA or placebo, respectively. There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x109/L or 0.5x109/L. Before initiating treatment with TECFIDERA, a recent CBC (i.e., within 6 months) should be available. A CBC is recommended
    annually, and as clinically indicated. Withholding treatment should be considered in patients with serious infections until the infection(s) is resolved. TECFIDERA has not been studied in patients with pre-existing low lymphocyte counts.

    17.4 Lymphocyte Counts

    Inform patients that TECFIDERA may decrease lymphocyte counts. A recent blood test (i.e., within 6 months) should be available before they start therapy to identify patients with pre-existing low lymphocyte counts. Blood tests are also recommended annually, and
    as clinically indicated [see Warnings and Precautions (5.1), Adverse Reactions (6.1)].

    Leave a comment:


  • shalimar
    replied
    white cell blood count

    My doctor wants me to come off Gilenya and go on BG12because my white cells keep dropping, but I saw in one of these messages that this new med also drops the white cells. Anybody know anything on that?

    Leave a comment:


  • samanthaelizabeth
    replied
    BG-12 PRESCRIPTION!!!

    GOING TO LAB TOMORROW FOR CBC BEFORE THIS MED IS PRESCRIBED TO ME!!! THANK GOD NO MORE COPAXONE SHOTS!!! I JUST HOPE I DON'T HAVE ANY PROBLEMS WITH THIS MED..I'M KINDA SCARED.

    Leave a comment:


  • zoysia
    replied
    I've been on this bandwagon for well over a year now, and finally!!!!!!!!!!!!

    Thanks for nothing, Teva! Three extra months for making us wait over "no so much"?

    My doctor squeezed me in next Tuesday, because we've been waiting so long and I NEED to do something for my M.S. I pray this works for me and all other MSers who are going to try this medication. I'm beside myself with joy today--Easter, nah! IT'S CHRISTMAS!!!!!

    Zoysia

    Leave a comment:

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