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September 22nd, 2010
09:19 AM ET

FDA approves first MS treatment in pill form

The Food and Drug Administration (FDA) has approved the first oral drug for treating relapsing-remitting multiple sclerosis (MS), the most common form of the disease.

Unlike current MS drugs, which are given by injections or infusion, this new drug, called Gilenya or fingolimod, comes in a capsule which is taken once a day.  Taking a pill is much less painful than having to stick a needle in your body on a daily, weekly or monthly basis, which is what many MS patients have to do now.   

"Gilenya is the first oral drug that can slow the progression of disability and reduce the frequency and severity of symptoms in MS," according to a statement by the FDA's director of the Division of Neurology Products Dr. Russell Katz.

Multiple Sclerosis affects about 2.5 million people worldwide, about 400,000 in the United States alone.  What causes MS is still not known.   It is a disease of the central nervous system considered where the body's immune system attacks the fatty layer that protects nerves in the brain, spine and eye.  As the fatty layer is destroyed, scar tissue forms which blocks the nerve signals and leads to a variety of symptoms including difficulty walking, vision problems and/or pain.

Gilenya is not an immunosuppressant, explains Dr. Nicholas LaRocca, Vice President of Health Care Delivery and Policy Research for the National Multiple Sclerosis Society.  Instead, he says, "it manipulates the immune system in a way that's beneficial for patients with MS."

According research presented by Novartis, the manufacturer of  Gilenya, this drug cut the relapse rate by 62 percent in newly diagnosed patients and by 44 percent in previously treated patients.

Taking a pill doesn't necessarily mean it's the safer says LaRocca. Like any drug, this one can cause possible side effects such as increased blood pressure, reduced lung function, eye toxicity, decreased heart function, and an increased risk of infection.   "We don't know for sure what's going to happen until the drug is on the market and it's been on the market a while and a large number of people have been treated with it," he says.  Patients should talk to their doctor to see if this drug is a viable option for them, say LaRocca.  He adds that some patients may just want to stay on the drugs they are on if they are working well for them.

Novartis is the manufacturer of Gilenya, and the company has promised to set up a program to monitor and educate patients taking the drug.  In June, an FDA advisory committee unanimously recommended approval for the drug Gilenya.  Back in January a series of clinical trials for Gilenya along with Cladribine proved successfull at reducing the rates of relapse and slowing the progression of disability.


soundoff (224 Responses)
  1. jim

    Gilenya probably will cost about $30000 a year in the U.S., source: bloomberg dot com story (today)

    September 22, 2010 at 16:58 | Report abuse | Reply
  2. Paul

    Its amazing that we can end polio but haven't eliminated any diseases since................. Drugs like this one do nothing to address the root cause of the disease. Its just another palliative treatment that works for some and cures nobody. I guess diseases like this keep a lot people in business. Treating the symptoms remains a far more lucrative business than curing the disease.

    September 22, 2010 at 17:17 | Report abuse | Reply
    • Steve

      You are Bang on Paul

      http://www.greenloop360.blogspot.com/

      September 22, 2010 at 19:41 | Report abuse |
    • Sandy

      I've been saying for years that drug companies don't want cures. They wouldn't make money with cures. The last one was when penicillin was found. There were no drug companies then.

      March 29, 2012 at 08:53 | Report abuse |
  3. JK

    It's very interesting to read stories about MS and the treatments and cures. I'm fortunate enough not to have MS, but my brother-in-law has PPMS, and we are his caregivers.

    My interest in this drug is merely for those of you fortunate to have RRMS. I'm intrigued by those who are forgoing any treatment because they are asymptomatic. The point of Copaxone, Avonex, etc., and this new drug is to prevent those future relapses, or at least stave them off a little. I'm not one to put anything into my body it doesn't need, but I'd love you to at least consider that over many years, that RRMS diagnosis can easily end up being Secondary Progressive. Then you're screwed.

    Also, those miracles out there? The CCSVI? Wahls miracle? I'm skeptical. Unless the studies are well-executed, use verifiable, reproducible effects... sorry, but the overpromotion of them provides a snake-oil element to the supporters that could just be solved with real research. Everyone with MS wants a miracle. Please don't sell them one. It's damaging and makes a bad situation worse.

    Also, for Dr. Wahls specifically... You're selling stuff. You're making money off your miracle. I only hope that you're riding BikeMS every year now that you're back on your bike! I know in our local BikeMS event (which I volunteer for each year), we had eight riders with varying degrees of MS.

    And for all of you out there with a personal connection to MS, I urge you to get involved with your local National MS Society and volunteer! There are other associations/nonprofits as well where you can help make a difference by volunteering or donating.

    Let's all hope this treatment, and others being researched right now, finally give a world free of MS.

    September 22, 2010 at 17:24 | Report abuse | Reply
  4. c

    The side effects sound very scary. I have mine under control right now without the use of drugs. For JK, I was unable to stand up and have balance with my last major episode. I was ready to do anything, until I read the side effects of the drugs. I decided to try something alternative. I have nothing to sell. I have RRMS. I had major episodes every 5 years, with symptoms inbetween. I have now gone 10 years without a major flare up. 10 years!!!!! Why? Nutrition. VERY careful nutrition. When I cheat, my body starts to react, and I can feel the rumblings...... so it encourages me to stay the path.
    I know I am fortunate.
    Everytime I see news of a new drug, I check it out. My eyes are already effected, so a drug that would cause more eye trouble is not for me.
    I have nothing to gain from telling you this. I also know of somebody who had your brother's type of MS.... he did GREATLY improve for many years with diet and exercise, but eventually got worse once again, and finally succomed.
    There are no guarantees with any treatment. But I REFUSE to be a guinnea pig for a pharmacy company.
    "we won't know how it works until a larger group of people start using it"...How many will have to die so this company can make money?
    Who's really selling something?

    September 22, 2010 at 17:44 | Report abuse | Reply
  5. Snerdle

    "Taking a pill is much less painful than having to stick a needle in your body on a daily, weekly or monthly basis"
    Well thanks Captain Obvious.

    September 22, 2010 at 17:47 | Report abuse | Reply
  6. Kristi

    I was diagnosed with MS in Feb 2010, and have been on Avonex, and it is working for me. I am cautiously optimistic about this new drug, but I think I will wit a bit before I run to my neuro for a script. The injections aren't fun, but I'll take them for now!!

    September 22, 2010 at 17:56 | Report abuse | Reply
  7. JK

    c: I'm really glad you're doing well! If what you're doing's working for you, I'm all for it. It certainly didn't want to come across as endorsing one treatment over another. Every case of MS is radically different, and I think that's why so many people – doctors and pharmaceuticals – have such a challenge about what the cause is and what is the best treatment.

    My brother-in-law, unfortunately, is a worst-case scenario. He's been on many different meds, none of which has done anything to improve his disease course. Unfortunately. And now, exercise is not an option. He's chair-bound with extremely limited mobility. I only wish that when he was able to take care of himself, he was more cognizant, as your were and are, about what he could have done to help slow his own progression. I make sure that when I'm home with him, he gets good nutrition.

    Apologies to anyone who thought I was endorsing anything other than solid research and getting involved. :)

    Cheers, and good luck to all of you with MS. Let's all hope there's a cure or at least a valid treatment soon.

    September 22, 2010 at 17:57 | Report abuse | Reply
  8. Cat

    This is really good news. I have been at this injection thing for 12 years and really tired of it. However, I'm going to stick with what I have until more is known about this drug. If it checks out...then iI'm so on board. Yeah for us who suffer!!!!!!

    September 22, 2010 at 18:06 | Report abuse | Reply
    • DM

      Read my post below, it may help you in your decision.

      September 22, 2010 at 18:19 | Report abuse |
  9. Mary Beth

    If it were so easy just to change ones diet and exercise and be rid of the MS ball and chain, don't you think everyone w/MS would be doing that? DUH I had a great diet, very little meat, lots of exercise and and great shape. Guess what, I got MS @ the age of 43!
    Can't wait for the pill!

    September 22, 2010 at 18:11 | Report abuse | Reply
  10. DM

    I have been on this drug for the past 3 years in a clinical trial. Although it has done well for me with my relapses, it also has its faults. Be sure you weigh all your options before jumping on this drug. I only went to it because I had no other option, I had become allergic to all of the shots & drugs that are out there. I have still had relapses, but none of them as bad as when I was off the drugs. I know they are saying this is NOT an immuniosuppressant drug, but I disagree. Your white blood count stays very low & you are more at a risk of catching things from common colds to the flu or whatever else is out there. I also received a very rare infection in my colon/intestines this past year, of course they are not sure if it is from the drug, but the only people who get it are on meds that lower their immune system. The infection had a 50% mortality rate, luckily I got through it, but was made to stop taking the meds for almost 2 months to fight it & get my immune system back up. I am not discouraging this medicine, I am going to continue to take it myself, I am just wanting people to be informed about it. If you are on a drug right now & it is working well for you, you may want to consider staying where you are & the risks that come with it. Good luck to all & I hope this helped!

    September 22, 2010 at 18:18 | Report abuse | Reply
  11. Catherine

    Very sad that so many shysters take advantage of news like this by posting false misleading info offering miracle cures. Here's hoping there is a special place in hell for them

    A point that has not been made but is huge. Regardless of the retail cost of Gilenya it is a pill and will have to be a pharmacy benefit. i can't speak for others but my health insurance covers MS injectibles as a durable medical equipement benefit (don't ask me why!) and make you pay up tp 25% of the retail cost. For Betaseron that is $800 a month vs. the maximum cost for a pill- $50. So while I am very interested in learning about the frequency of the side effects i am almost as anxious to see how it will be priced.

    September 22, 2010 at 18:23 | Report abuse | Reply
  12. Vrginiai

    So, where are the LDN (low dosenaltraxone) users and their stories about MS......?

    September 22, 2010 at 18:32 | Report abuse | Reply
  13. Mido25

    If it is known in that pill medicines always come with mild to severe side effects, then why are they endorsed? In fact, did you know that only in the United States do they have advertisements for pills. In no way do I endorse this! The shots may be old fashion, but one they are safer for you and two, they are known to be more effective than a pill. The pills come with many dangerous side effects, thus why should we put patients at risk of contracting something worse in addition with MS just to avoid the sting of a needle from a shot.

    September 22, 2010 at 19:04 | Report abuse | Reply
  14. Carl

    If anyone finds benefit in a pill over injections, but is worried about the side effects, I suggest keeping an eye on this drug even if you don't want it yet. Of course some drugs end up causing more side effects than expected. But sometimes horrible-sounding side effects in early trials are found to be limited to a small subset of patients, and many people will be able to use the drug in question without problems.

    September 22, 2010 at 19:07 | Report abuse | Reply
  15. T

    My sister was diagnosed with MS when she was 30. She passed away in December at the age of 55. She was so young. There weren't any really helpful drugs at that time. Our family had to put her in a nursing home when she was in her 40's. So young but she needed more help than we were able to give her. It's exciting to read that drugs are helping people. My sister was a stoic and beautiful person and terribly missed. I wish everyone luck in dealing with their MS.

    September 22, 2010 at 19:16 | Report abuse | Reply
  16. Steve

    CCSVI the Liberation of multiple sclerosis is a better choice and has more positive results. But BIG PHARMA does not make any money off that !! BIG PHARMA does NOT want a cure for MS they want to keep the disease going and come up with pills to increase their bottom line Oh yes and CNN never reports on CCSVI because mainstream media is CONTROLED to a huge extent by BIG PHARMA see the connection ?

    September 22, 2010 at 19:22 | Report abuse | Reply
  17. Colleen

    Does anyone know what the recommend dosage is for Vitamin D for MS patents?

    September 22, 2010 at 19:24 | Report abuse | Reply
    • alex

      that requires testing to determine what your baseline and response to the dosage is. i started at 10k iu a month, and am up to 50k iu a week now just to get my count to mid range normal. it does help though, and the overdose levels are very high, so little risk of that.

      September 22, 2010 at 20:01 | Report abuse |
  18. Dana

    john
    I cant believe this, now drug companies can profit off a pill when all thats needed is a stence to clogged veins in the neck.
    --
    What, pray tell, is a "stence"? Are you talking about a "stent"? If you can't even figure out how to spell it, you're too dumb to be posting medical advice to anyone.

    September 22, 2010 at 20:07 | Report abuse | Reply
    • Steve

      Dana who cares about the spelling. John is right You are the one who is too dumb to realize the deception of the pharmaceutical companies. Go back to sleep you SHEEPLE

      September 25, 2010 at 18:37 | Report abuse |
    • Amy

      Dana–I'm on your side and laugh off anyone who believes in conspiracy theories of pharm. companies. The medical community is not comprised of amoral devils people!! Yes, drug companies make money, but they often make drugs that save lives! What about protease inhibitors that prevent AIDS? What about various cholesterol medications that control plaque in our arteries? There are many more successes than there are failures and no one should be called a "sheep" because they embrace new medicine.

      October 4, 2010 at 17:21 | Report abuse |
  19. Cheryl

    I was diagnosed in "87 before the ABC drugs. Then I tried Beta Seron and Avonex. Quality of life was AWFUL! I had every side effect in the book and am convinced they made me worse. My neuro and I did not even attemp the other injectibles. I spent years waiting for the side effects to ease up or disappear. The drug ads always show smiling, energetic people, who are walking, riding, playing sports. I lived the dark side that the company line never shows. Yes, I am in a wheelchair, but have been absolutley stable for almost 15 years and teach high school full time. I am past the relapsing, remitting phase, but would never rush out to try this new drug even if I qualified. Give it time to reach a larger sample.

    September 22, 2010 at 20:22 | Report abuse | Reply
  20. Mollie

    I was diagnosed with RRMS in 1993 and have been doing some kind of interferon injections since 1994. I'm tickled pink to start this new drug. We wouldn't have any medical progress if patients weren't open to starting new therapies. I understand that the study group for this drug was large (over 2000 patients) and the improvement rate was better than anything else to date.

    I'm 58, my kids are raised, and I have the time to focus on myself. I'd like to be considered for this drug when it's available. Put a call into my neurologist already this am and I'm hoping for the best!

    September 22, 2010 at 20:27 | Report abuse | Reply
  21. speck

    Big Pharma is going to lose an absolute fortune on Liberation Therapy, and they know it. What a surprise that suddenly, your most hated injection is now in easy-to-swallow pill form.

    September 22, 2010 at 20:37 | Report abuse | Reply
  22. Brian Cole

    I have been on Fingolimod for over two years after being on Avonex for 10 years. The thought of going off Avonex was tough because it had worked so well for me, Fingolimod has been just as effective for me AND NO SHOT!!! I have not suffered side effects and I was diagnosed in 1996 so this has been great. I am not a medical professional and this is not a recommendation . Please consult your medical professional but in my humble opinion this drug works as well as Avonex.

    September 22, 2010 at 21:24 | Report abuse | Reply
  23. Michelle

    My neurologist said this is a low dose of Chemotherapy. I am not so sure this is a great thing to be taking. I mean – It has not been tested for very long. I have MS and i take a shot 3 times a week, trust me, a pill sounds much more delightful, but Chemo sounds VERY scary!

    September 22, 2010 at 21:27 | Report abuse | Reply
    • KJG

      Michelle – I have been in the clinical trial for this drug and it is NOT low dose chemotherapy. Your doc has it confused with a different med.

      September 23, 2010 at 01:01 | Report abuse |
  24. Jen

    I was diagnosed on valentines day 2005 and have been on rebif. Knock on wood I have not had a relapse. Lesions have gotten smaller and granted I don't always feel my best. The pill scares me. If its not broken. Don't fix it. I'm 34 and want to have a baby but afraid to get off my shots the disease does not own me. I own the disease. It does not define who I am. So may people need to get educated on this disease. I'm scared for my future but need to live life to the fullest. All ms people do. We never know what will happen tomorrow!

    September 22, 2010 at 23:10 | Report abuse | Reply
    • april

      dear jen i was dx with ms aug this year i take avonex and i dont have no side effects yet so i'm staying with it i just want to go and get a mri done and them saying the spots are gone or stay the same and beable to walk and do things i think thats all ms people want to know what every were taking it stop it and are disability are what they are and we have to live with it. my balance is off and memory well not the best and i do things slower but i'm here. god will find a person to find a pill or shot to stop this. i never understood why they cant put avonex and all the other shot meds in a pill form that would make sence to me . god is with us and they did come along way for ms and its only going to get better then the cure love april

      September 24, 2010 at 18:03 | Report abuse |
  25. Jen

    Oh and with my own assumption of what ms is caused from. My whole mouth is full of the old mercury fillings. Plus I had mono virus as a teenager. I believe those could be a related factor. Being on the meds and the mri's I've had. Show there is improvement and has stayed stable. I started a support group for newly diagnosed in my town and we meet once a month. We don't even talk about MS anymore. About our lives in general. We CHOOSE how deal with it.

    September 22, 2010 at 23:20 | Report abuse | Reply
    • Lex

      Hi Jen,

      I was recently diagnosed with MS and I am not sure how ro proceed. I am 46 and have a great deal of trouble moving around and walkign. If you have a blog about this or would be willing to have me join your support group online I sure could use both the information and insight from the group. Thank you

      March 3, 2012 at 09:32 | Report abuse |
  26. Lo

    This is great I have to give my dad shots every weekend. I can't wait to tell him about this

    September 23, 2010 at 08:54 | Report abuse | Reply
  27. nan

    I was diagnosed with RRMS in Feb 2010, have been on Copaxone since June and have the welts and itching from the daily shots. Ice and heat didn't help,but I can't complain. The muscle cramps and weakness seem to be less and I am greatful for that. I would love to take a pill rather than the daily shots. I will need to check into the side effects further before making a decision.

    September 23, 2010 at 12:43 | Report abuse | Reply
    • M from Boston

      I have been on Copaxone since 1998 and it gets much easier over time. The itchy welts will lessen over time but will still happen once in a while. I might go 2 months with a perfect injection then BANG I get an itchy welt on the next one. But much eaiser and less in time. Not sure why or if it is just me. If its working dont mess with it. Thats my thinking. I will not try anything new as long as I am doing good on my Copaxone. Good luck to you. M in Boston

      March 3, 2012 at 09:17 | Report abuse |
  28. cheryl

    I was pretty excited to hear about the pill becoming available until I read about the possible side affects. I've been on copaxone for ten years and looking back had symptoms for another ten. One thing that impressed me is the info some of you receive from your neuro. My first neuro asked me if I wanted to take a shot every day, every week or every month. My sister-in-law recommended Copaxone,which has worked really well for me. He also asked me if I had internet access and told me to look up MS,where there would be much info there.

    September 24, 2010 at 21:36 | Report abuse | Reply
  29. cheryl

    And I have used the Auto-Injector the whole time with usually good results. I have had to get new ones periodically.

    September 24, 2010 at 21:48 | Report abuse | Reply
  30. Ryan

    HA. Christine your obviously uneducated on what ms is

    November 5, 2010 at 10:38 | Report abuse | Reply
  31. SnYperEyes

    I've recently been diagnosed with RR-MS. I'm absolutely terrified of needles but definetly agree with some of the posts on here as far as this being a new drug that's just been approved, I'm thinkin' I might want to hold off on actually trying this one for myself until more is learned about the "other" effects it may have. Because I am terrified of needles I've kinda held off on the injection thing...I like to read, read & read about these kinds of drugs because of their side effects. I'm thinkin' I'm gonna suck it up and possibly try this Avonex thing......any feedback on that one????

    November 22, 2010 at 15:19 | Report abuse | Reply
    • Marcus

      I was diagnosed with RRMS Janurary 2002. My Neurologist started me on Avonex. It didnt work well for me due to the side effects and intramuscular injections. I moved from NY to NC six years later and my Newest Neurologist suggested I try Copaxone. I did and it is working a lot better for me. Copaxone is still taken by enjection however, its injected under the skin and not directly into the muscle. I hope I've helpful or informative for you.

      October 21, 2011 at 17:35 | Report abuse |
  32. Brittany

    Along with all of you, I am also an MS patient. I'm currently 18, and 2 years ago, I was diagnosed. I was the youngest person in my hospital to even have any sign of this disease. As of right now, I am taking the Betaseron shots every other day. I have been taking these shots for a little over 2 weeks now. When it first took effect on me, all of the known symptoms hit me at once. 2 weeks later, I had another episode, and my parents decided it was just about time I went to the hospital. I didn't want to go the first time it hit me, and I agreed upon it the second time only because I didn't know what was going on. A week after being in the hospital, and after all the tests they ran on me, they found out I had MS. They immediately started me on Tysabri. For 24 months, they had me on this drug that I have to take a visit to the hospital for every month to get the infusion. This has worked wonders. In no time at all, it started to work. Ever since that episode 2 years ago, I haven't had one. Now tell me this medicine isn't amazing. I absolutely hate needles, and my mom is the one who has to give me my shots. Even being scared by these needles, I agree with the posts on here. No way am I taking a pill with this many side effects. Yes, it would be less painful, but at these risks? I don't think so. Has anyone else ever tried the Tysabri?

    November 27, 2010 at 05:28 | Report abuse | Reply
    • Lex

      Oh my gosh you are so young to have to deal with this. I hope you can find a hobby, craft or sport that will let you forget even if for a short while about MS. Best wishes.

      March 3, 2012 at 09:36 | Report abuse |
  33. Herbert B manning

    am87 years old&have M S since I was 40. Take COPOXNE.I Started taking it the day it became available.Two rel apes in all this time.The new needle is so small I do not feel it.Live in a senior residence and in better shape than most of the residents that do not have MS.If my story helps just one person I Will be happy

    January 29, 2011 at 23:10 | Report abuse | Reply
    • Lex

      87 years old and young. You go guy :)

      March 3, 2012 at 09:38 | Report abuse |
  34. bill meyer

    been diagnosed with ms, i'm 49,had my first attack 10 years ago,it affects my eyes,loose sight but then it comes back.10 years to the month in december 2010 it came back in the other eye.well i then had all the tests mri's spinal tap.they want to start me on treatment but i'm not fully confident in the meds,if its not going to cure it what is the benifit?also what about feeling tired and aching all the time,what can help that.if anyone can be of assistance i would be thankful. GOD BLESS!

    May 4, 2011 at 09:54 | Report abuse | Reply
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    Take a look, if you need any of legal forms.

    October 22, 2011 at 23:24 | Report abuse | Reply
  36. Pamela Kay Carpenter

    Is Gilenya or Fingolimod a streiod or anything like it? Does it also, have side effects that will cause great weight gain ? The Copaxone therapy does cause weight gain of up to 40 or 50 pounds in persons taking it for many years?

    May 20, 2012 at 14:09 | Report abuse | Reply
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