Biogen Releases New Data Showing Effectiveness of Tecfidera in Newly Diagnosed MS Patients at AAN 2016

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multiple sclerosis clinical trial results

Biogen reported new data describing the effectiveness of Tecfidera (dimethyl fumarate) in newly diagnosed relapsing-remitting multiple sclerosis (RRMS) patients in a recent presentation at the 68th annual meeting of the American Academy of Neurology (AAN). The conference, taking place in Vancouver, Canada, runs through April 21.

Tecfidera is an oral medication taken twice daily. Although the biological activity of this medication is not completely understood, researchers believe that Tecfidera inhibits immune system cells and molecules. It may also act as an anti-oxidant, potentially protecting against demyelination and the loss of neurons that occurs in MS. Tecfidera has also been used to treat other inflammatory diseases, including sarcoidosis, psoriasis, and necrobiosis lipoidic.

Previous clinical trials on Tecfidera have shown immune-suppressive effects in people with MS, a reduction of relapse rates, and an increase in the time to MS disease-progression compared to placebo (a sugar pill).

More than 50 percent of the newly diagnosed MS patients who received Tecfidera experienced no relapses and disability progression for a total of six years. Additional data derived from a U.S. healthcare claims database confirmed lower annual relapse rates compared to glatiramer acetate, interferon β, and teriflunomide. Scientists reported similar relapse rates between Tecfidera and fingolimod (Gilenya).

“The MS treatment landscape has expanded rapidly in recent years, giving physicians and patients options for various stages of disease. Beyond clinical findings, real-world data provide important insights into patients’ experiences outside of clinical trials,” Kate Dawson, MD, vice president, U.S. Medical at Biogen, said in a press release. “These data show Tecfidera consistently delivers strong and sustained efficacy in newly diagnosed patients both in a real-world and clinical setting, further supporting the value it offers patients and affirming the advantages of early treatment with Tecfidera in decreasing clinical disease activity.”

Biogen produces other medications, in addition to Tecfidera, for the treatment of MS, and is also making additional presentations on those drugs at the AAN Meeting. The company gave its Tecfidera presentation on Monday, April 20.

“MS is a complex, life-long disease that affects each person differently. Because people with MS have diverse treatment needs, it is critical that they have a variety of therapeutic options available that not only provide robust efficacy and different mechanisms of action, but also offer the flexibility to transition to another treatment, if needed,” concluded Ralph Kern, MD, senior vice president, Worldwide Medical at Biogen. “With the world’s leading MS portfolio and growing pipeline, Biogen continues to focus on MS care to impact the greatest number of people living with MS globally.”

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  1. S says:

    Really! This is news? Rehashing the same old drugs? Funny I called Biogen and asked how much money they put into a cure, no answer. I did learn…..

    “The annual compensation of Biogen CEO George Scangos may have fallen by $1.8 million last year compared to the previous one, but he made up most of that in the value of stock he owns that became available to sell.

    Scangos, who has been at the head of Biogen (Nasdaq: BIIB) since 2010, realized $32.3 million in the value of shares of stock that vested in 2015, an uptick from the $31.2 million he got the year before. That almost, but not quite, makes up for the fact that the total of his salary, new stock awards, non-equity incentive plan pay and all other compensation was $16.9 million this year, a 9.4 percent drop from 2014.”

    Hmmm…….where does all the money for a cure go?

    I am not a depressed person I have a depressing disease. I wonder why? Biogen is rehashing there same old drug,it is not news . Funny I learn more about my disease in the business journals and the stock market. Sorry you were not around to speak with me Mr. Scangos. I tried.


  2. Beatrice says:

    I have to agree with the above poster. Are they even trying to cure MS anymore or just keep people on a rigid medication regimen for the rest of their lives? It is sadly very obvious that a cure would be the worst thing to happen to the drug companies.

  3. Jeanine says:

    I wholeheartedly agree with the above statements. I am sick of the drug companies exploiting people with debilitating diseases. The expense of these drugs is off the charts. There is no financial incentive to look for a cure or an old drug that may help.

  4. s says:

    I went to my GP today and was asked by a nurse, ” Well you should be fine with MS now right? I have seen those ads on TV for that drug. “No, I am not fine!

    This out today

    “Biogen has been trying to reignite sales growth for Tecfidera following an unexpected slowdown last year. In the first quarter, Tecfidera sales rose 15% to $946 million.

    Sales of the drug had been pressured as fewer new patients were being prescribed the drug, in part because of doctors’ concerns about a rare side effect that was linked to a patient death last year.”

    • JM says:

      that is exactly why I don’t take it. I am JC+ and at risk for developing PML (the deadly brain infection this person died of…along w/ 4 other ppl). Even though I’ll be ‘monitored’ I can’t bring myself to risk it. I have Copaxone in my fridge but haven’t started. Really want to treat this naturally via Dr. Terry Wahls and my functional medicine MD.

  5. John says:

    Actually, Biogen has a drug in development (ongoing studies) that actually remylinates. They also have been spending money on safety and efficacy studies because of the PML that occurred, many Dr’s were spooked and have requested more data. Lastly, this is not a “new” study, it is an analysis of the current studies, and info provided by healthcare claims in the US.

    Not that it applies to you but they have also invested $3-5 billion into an Alzheimer’s medication.

    Every drug company, biotech or not, is in it to make a profit but Biogen is one of the few that is actually heavily investing in new therapies. It’s not the evil company you’re making them out to be.

    • Clayton says:

      Thank you John.
      While I am also emotional about having this disease, I am grateful companies are investing in new treatments. I tolerate Tecfidera better than I did Avonex, and any benefit from the treatment is better than no treatment, to me.
      The treatments only exsist because money was invested to investigate their discovery, I am grateful it is profitable enough for companies to spend enormous amount of money researching a treatment.
      My heart goes out to all of the scientist and researchers, and the continual pursit of knowlege.

      • Heather says:

        Tecfidera was used in Germany for psorisasis (dimethyl Fumurate). They reformulated this drug and raised the price substantially and put it back on the market for MS. wth.

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