Multiple Sclerosis Pill Approved by U.S. FDA

    September 14, 2012
    Sean Patterson
    Comments are off for this post.

The U.S. FDA this week approved a once-a-day pill for the treatment of multiple sclerosis (MS). The pill, being branded as “Aubagio” by Sanofi S.A., is specifically for the treatment of adults with relapsing forms of MS.

“In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo,” said Dr. Russell Katz, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research. “Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients.”

According to the National Institutes of Health, MS is a chronic autoimmune disease that affects the central nervous system. It disrupts the communication between the brain and the body, causing motor skill disruption for nearly every part of the body, depending on which nerves in the brain are damaged.

As for the drug itself, side effects seen during drug trials included diarrhea, abnormal liver tests, nausea, and hair loss. Also, the box warnings for the drug warn of possible liver problems and fetal harm, including the risk of birth defects. Doctors will have to check patient’s liver function and give a pregnancy test before starting treatment with Aubagio.

“Many people living with MS struggle with the additional burden of injectable therapies administered daily to weekly,” said Dr. Aaron Miller, medical director at the center for multiple sclerosis at Mount Sinai Medical Center. “The FDA’s approval of Aubagio, a new oral treatment option, is an encouraging advancement for the MS community and may be a valuable treatment for people living with this often debilitating disease.”

  • http://yahoo CM

    I have 2 friends w/ MS , hope this pill turns out to be a help for them .

  • Mario Salamanca

    I have MS of the Secondary Remissive Type. And I am taking Interpheron injected. this could be a fantastic alternative for me. is it an effective substitute to Interpheron?
    Although I have asked my Dr. This could be a great benefit for many people like me with the disease.
    Mario Salamanca

    • Jessica Manning

      There are many effective options to interferons. As an MS sufferer myself, I take Copaxone. It is MUCH better than any interferon ever was for me.

  • Adam

    i have high hopes for this new pill to work my mom has MS an has had it for at least 12 yrs I will agree that if It wasn’t for the injection treatments then she would be bed bound for the rest of her time but her MS has gotten so much worse she went from taking one shot a week to one shot every other day so I will have her ask her dr about this new pill I have high hopes

    thank you,

  • Jack

    My mom has had MS since just after my older brother was born, about 26 years. However, she didn’t really present with noticeable symptoms until four years ago. The doctors think this was due to the low-fat diet she was eating, which really helped keep inflammation down in her body.

    Pills and injections are fine, but you should also manage your diet. I recommend looking into the Swank Diet. It takes a complete lifestyle change, but it’s helped keep my mom healthy and happy.

    • Jill

      Kudos to your mom! I too have MS, changed my lifestyle and have done well. Thanks for sharing this information and being supportive of non-medicinal regimens for MS.

  • Melanie

    I really hope this pill works! My father suffered from MS for over 40 years before it finally took him away from us a few years back. If this pill can help subside any symptoms for MS patients then I am all for it. Good luck to those of you who are currently battling MS. I hold you all near and dear to my heart.

  • Minnie

    Have had MS since 2000. Went on Avonex for 1 year. Thought I was supposed to be in pain until my neurologist told me I was not. My problemniw is arthiritis– cannot tell if it is MS or Arthur.

  • Steven Raines

    I want a better alternative than what is currently available. I hope this is the one that sets us free from the symptoms and manifestations of this illness.

  • jeanne

    Therapy for MS begins with an informed doctor. If your current therapy works…….stick with it. I have not had a relapse in over 10 years, with a 28 year history of MS. (Avonex injections plus methotrexate) Tomorrow may be different.
    The best medicine I have is my mother’s attitude since she had MS since I was 4 years old; once numb from the waist down (at age 52); now you wouldn’t know to look at me; one nerve at a time: our body wants to heal. Find a way to be positive…..fight the dark side of MS.

  • Deborah Vanderhulst

    Does anyone. ANYONE!! care about secondary progressive ms????? STOP not doing anything about a f……g disease that destroyed my entire family, do research etc. for the other kinds too.

  • Gracie Ellen Lamb

    I havve a daughter and a grandaughter who have MS my daughter found out about 13 yr ago, she had a spinal tap done came back postive and my Granddaughter found out about 3yr ago she was having vision problems went to eye doctor he seen lesions and she had a spinal tap. they both take one a day shots.

  • Gary Anderson

    As an MS sufferer I am takibg Copaxone. It is reducing symptoms and has minimal side effects unlike copaxone (interferon). Copaxone does not give me flu-like symptoms.

  • Michele

    I’m new to MS and Im lost! I guess I could pay for an entire day with my Dr. to understand more? Im on my 7th weekly injection of Avonex! The most recent was a horrible experience! Im really afraid to experience such a nightmare agai! Scared enough to stop the treatment altogether! Have NO more tears!

    • Debbie

      I have been taking Gilenya since Feb 2012. I love the once a day pill, no more needles!! Works great for me.

    • http://yahoo walter

      I’ve been taking avonex for eight years now, and it does get better. My doctor also gave me a sleeping pill prescr. and so I do my shot and sleeping pill at the same time. I then can sleep through the side effects of the shot.