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New oral MS drug apprved by FDA

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  • New oral MS drug apprved by FDA
    March 27, 2013

    3rd Oral Drug to Treat MS Is Approved by the F.D.A.


    A chemical once used to treat sofas — until it was found to cause rashes and blisters in people who sat on them — is now poised to become a major therapy for multiple sclerosis.

    The Food and Drug Administration on Wednesday approved the chemical, dimethyl fumarate, which will be sold by Biogen Idec under the name Tecfidera, the third of a spate of oral drugs that are transforming the treatment of multiple sclerosis.

    Despite the drug’s seemingly odd history, Wall Street analysts, doctors and patients expect Tecfidera to become a blockbuster because of its combination of efficacy and relative safety and the convenience of being a pill. Doctors and analysts say some patients have been putting off starting treatment until Tecfidera is available.

    Feedback from doctors was “highly positive, with a strong consensus that Tecfidera offers a more favorable clinical profile than other oral or injectable first-line options,” Thomas Wei, an analyst at Jefferies, wrote on Monday.

    About 400,000 Americans and more than two million people worldwide have multiple sclerosis, many of them women first stricken in their 20s. The disease is believed to occur when the body’s immune system attacks the insulation around nerve fibers, causing symptoms like difficulty walking, blurred vision and fatigue.

    The market for MS drugs is already $14 billion annually, with $8.5 billion of that in the United States, according to Sanford C. Bernstein & Company.
    While self-injected medicines like Avonex from Biogen and Copaxone from Teva that entered the market in the 1990s are still used by the majority of treated patients, newer oral drugs are making inroads. In addition to Tecfidera, the other two oral drugs are Gilenya from Novartis, approved in 2010, and Aubagio from Sanofi, approved in September.

    The approvals will solidify Biogen’s position as a leader in multiple sclerosis drugs. In addition to Tecfidera and Avonex, the company also sells Tysabri, a highly effective intravenous drug but one that can cause a potentially fatal brain infection.

    Biogen shares have more than doubled in the last two years, largely because of anticipation about Tecfidera. The shares closed on Wednesday at $182.68, up about 3 percent.

    Biogen, which is based in Weston, Mass., did not immediately announce the price of Tecfidera, which was known as BG-12 during its development.
    Stock fund portfolio managers polled by the research firm the ISI Group on Wednesday predicted a price of about $51,000 a year, which would be roughly in line with prices of the injectable drugs, but less than the $60,000 a year list price of Gilenya.

    The effectiveness of multiple sclerosis drugs is often judged by how much they reduce the frequency of relapses, which are severe flare-ups of symptoms, compared to a placebo in clinical trials.

    The injectable drugs reduced the frequency about 30 percent, as did the new oral drug Aubagio. Gilenya cut the rate about 54 percent.
    Tecfidera cut the relapse rate 44 percent in one trial and 53 percent in another, which might put it a bit behind Gilenya. Tecfidera is also taken twice a day, while Gilenya is taken only once daily.

    But Gilenya has side effects that make it off limits for some patients and require careful testing and monitoring for heart, liver and eye problems. Patients are supposed to remain in a medical facility for at least six hours after taking their first dose to make sure their heart does not slow down too much.

    Tecfidera will have fewer restrictions and testing requirements. The prescribing information does recommend that blood cell levels be tested before a patient starts on the drug and annually thereafter. That is because Tecfidera can reduce white blood cell levels, leaving patients potentially vulnerable to infections. And some studies in animals suggest that the drug might cause fetal harm, making it a questionable choice for pregnant women, the label says.

    Tecfidera’s most common side effect is flushing, which occurs in about 40 percent of patients. The drug can also cause nausea and diarrhea.
    Dimethyl fumarate and some closely related compounds are simple molecules that have been used as food additives. The compound was also used to protect upholstery and shoes from mold during storage. But people in Europe developed skin irritation and other problems, causing its

    Last edited by Random; 03-30-2013, 08:16 PM.

  • #2
    Interesting coincidence that I should come across a post on this topic, now. Just last night I was having a conversation with a few people about this very thing. Turns out there's an all-natural way to activate the Nrf2 pathway (which is how Tecfidera is thought to work), far more effectively and for far less cost.

    Protandim is a natural herbal Nrf2 synergizer, that....according to a research paper funded by Biogen themselves, is more effective at doing the job than their own new superstar, ex-sofa-cleaner drug. Here's a link to the paper:

    The take-home message:

    1. BG-12, tBHQ, SFN and protandim are well-tolerated and strongly induce Nrf2-driven antioxidant enzyme production in oligodendrocytes, with protandim showing the most potent induction.
    2. Nrf2 activators are able to protect oligodendrocytes against ROS-induced cytotoxicity.
    Conclusions: Our findings indicate that several Nrf2 activators are able to significantly increase antioxidant enzyme production in oligodendrocytes. Interestingly, protandim, a dietary supplement consisting of herbal ingredients, was the most potent inducer and therefore may be the most suited as a therapeutic strategy.

    It was just announced that the wholesale cost of Tecfidera will be about $55,000/year...or $4,600/month. Protandim can be had for $40/month, is more effective, with no side effects and carries a laundry list of other potential benefits, to boot. If anyone is interested in learning more of the story...message me and I'll be sure to get you the info you need....


    • #3
      very interesting information thanks for sharing

      The SCI-Nurses are advanced practice nurses specializing in SCI/D care. They are available to answer questions, provide education, and make suggestions which you should always discuss with your physician/primary health care provider before implementing. Medical diagnosis is not provided, nor do the SCI-Nurses provide nursing or medical care through their responses on the CareCure forums.


      • #4
        Protandim is a MLM scam promoted by a company call Lifevantage. They also claim it makes you live longer.


        • #5
          Originally posted by t8burst View Post
          Protandim is a MLM scam promoted by a company call Lifevantage. They also claim it makes you live longer.

          Thanks for the heads up, T8. For those thinking of trying Protandim for MS please do your own research and check with your doctor on whether it could cause reactions with any regular MS meds you take.
          Courage doesn't always roar. Sometimes courage is the quiet voice at the end of the day saying, "I will try again tomorrow."

          Disclaimer: Answers, suggestions, and/or comments do not constitute medical advice expressed or implied and are based solely on my experiences as a SCI patient. Please consult your attending physician for medical advise and treatment. In the event of a medical emergency please call 911.