Merck KGaA announced on Friday that its oral drug for multiple sclerosis should be coming soon. Merck just released data from a trial that showed patients taking its drug, cladribine, had 60% fewer relapses compared to multiple sclerosis patients taking a placebo pill. The study lasted for two years and involved over 1,300 multiple sclerosis patients.
A 60% reduction in relapse rate would make cladribine about twice as effective as the current multiple sclerosis treatments (like Avonex or Copaxone) that require routine injections. Merck hopes to submit data to register the drug in the U.S. in 2009.
Still in the works for cladribine are figuring out the long-term effects and the severity of side effects. Clabridine has been used to treat leukemia since the 1990s, by reducing the number of circulating lymphocytes (both B cells and T cells).
A 60% reduction in relapse rate would make cladribine about twice as effective as the current multiple sclerosis treatments (like Avonex or Copaxone) that require routine injections. Merck hopes to submit data to register the drug in the U.S. in 2009.
Still in the works for cladribine are figuring out the long-term effects and the severity of side effects. Clabridine has been used to treat leukemia since the 1990s, by reducing the number of circulating lymphocytes (both B cells and T cells).
Merck also makes Rebif, an injectable interferon-based MS therapy, although it is marketed in the US through Serono.
Do you feel like they are rushing to get this drug approved? Two years doesn’t seem like a long enough time to study a new drug especially for chronic illness like MS.
It has been in the works for quite some time. I’m all for it! I have taken shots since 1996 & am ready for something new. Besides, when I am ill someone else has to give the shots & I don’t really have anyone to do it. This would be much more convenient for me. I just wonder what the cost will be, can’t be any worse than the injections.
I believe cladribine has the potential to be the biggest MS drug ever. Most people hate getting shots every other day or every week, depending on what you’re taking. Having a pill to pop every day or whatever the schedule is will be great for the day to day suffers of MS. But, the long term effects of cladribine are yet to be discovered. Right now, the drug is given via infusion for a short time to leukemia patients…
As for price… you’d think it’d be cheaper than say Avonex, which is well over $1000 a month around here. And, no shots.
@Nikki: so what? Tysabri is also an euthanasia alternative, since so many people WANT to take it.
@Ken: blah blah blah, “potential”. We want results. And stop guessing prices, that’s just moronic. A cure has no price.
@Julie: “had 60% fewer relapsed”?
You might need a spellchecker.
Thank you, PmB, for pointing out my typo. Letting spelling errors and typos into my articles and blogs is one of my pet peeves and I am always happy when people catch the ones that I miss. As long as we are striving for accuracy, I would be very careful throwing around the word “cure” when it comes to MS. As much as I would love to think that a true cure is on the horizon, none of the therapies that are in the pipeline claim to be a “cure,” but improved disease-modifying therapies (or improved delivery systems of existing approaches, in the case of the nasal spray interferons).
This would be great! I think with any meds there will be concern. I don’t take anything right now and I wont untill they get that pill out! GO MERCK!
Julie,
This is slightly off topic but I didn’t know where to send you an email. I just wanted to thank you for everything you are doing. I found ms.about.com when I was diagnosed in 2006 and I constantly visit and I have subscribed to your newsletter and I am so happy I did. I always learn something. Thank you and please keep up the great work.
I hope this will make sense. English is not my first language!
Please take care of yourself!
Careful review of medication has shown some side effects that need to be addressed before placed on the market. I am hopeful for the drug but a thorough warning needs to be placed on medication by Merck & the FDA.
I think it needs to be studied a little longer. and I want to do more research before I would decide to try it.
Is a “60% reduction in relapse rate” really “twice as effective as the current multiple sclerosis treatments”? Can someone point me to an apples to apples comparison?
i have read (forgot where) that the nasal spray medication is more effective on MS patients that oral medication, and this has to do with how the medication delays or decreases MS symptomes (which is why we have injections in the first place and not pills). so some companies r working on creating nasal spray medication…have u heard this before Julie?
also, one more thing Julie and it could be out of subject, can u tacle MS medication and Pregnancy? should we stop the medication before getting pregnant or can we get pregnant while being on med and then stop the med once pregnancy is confirmed? MS patients r 80% women of child bearing age and this subject is still based on speculation. thx
I would like to know if any of these new drugs are going to be for more progressive types of MS. I was diagnosed in 1998 and my doctor told me I would just decline without having relapses and the is exactly what I have done. I am no spring chicken. I am 62 and I was diagnosed at 51.
Hi kookayeh- To be honest, I don’t know much about the mucosal (nasal spray) delivery mechanism of interferons. I do know that the protein does not do well in the GI tract, which is why we have the injections. To answer your second question, I have an article entitled How Long Do I Have To Stop My MS Drug Before Getting Pregnant?, as well as a broader article on Top 10 Pregnancy Questions for Women with MS. I hope these help.
To Scilla- Thank you for the nice compliment. I always love to hear that my writing is helping someone and that I am communicating effectively. You made my day brighter with your comment!
Marie:
I just read a post on a GREAT Facebook group called Fight MS by a woman who has been in the cladribine trial for a couple years and she has secondary progressive MS. She has been major relapse free for the entire time. So, to answer your question, yes, these drugs are being tested for the more aggressive forms of our lovely lifetime pal.
Also: the current crop of drugs are all about equally effective, except for Tysabri and mitoxantrone (sp?) which are more effective but more risky. The most commonly prescribed treatments, the interferons and Copaxone, are about 30 percent effective and according to one published study may not work for about 1/2 of us. So, the thought of a pill that works at 60 percent efficacy is awesome.
Also, the drug cladribine, as the story states, has been used for years as a cancer drug. So, there’s lots and lots of data on the drug, it’s hardly just two years and “here you go, general public, good luck.”
I hope and pray we have a pill soon. I hope it’s less expensive that my shots. I have been on Avonex for over 10 years and I still have bad flu like symptoms and I am getting to the point that my good days are getting fewer. When I first started out I only had one evening of flu symptoms. The last couple of years I am having injection site redness, three days of flu symptoms and bad depression. The cost is so high, my husband can’t retire (he’s 71) because we need his insurance to pay for my shots. No one wants to insure me because of MS or it’s so high we can’t afford out of pocket expense. Yes, I guess, we needd to sell our home. Yes, my MRI’s are great, but that doesn’t pay the bill or take care of my daily illness problems. So Merck, please get the pill on the market soooon… I’ll be first in line. I tired of my neurologist telling me how great my MS is doing. But at what quality of life. I have none…I have given up almost everything due to being sick all the time. I use to love to walk and go places. Not any more. So really is Avonex really helping me..Want something better…Carol
avonex hospitalized me
I will be so happy if they get an oral drug for the treatment of MS soon this taking shots is so hard to do every other day taking a pill would be so much easier and probably less expensive.They say a pill will be here at the end of the year let’s pray that’s so.
I was diagnosed in late February early March 2009. My second opinion told me I have had this since I was about 15 yrs. old. I think it was triggered by the death of my father in 2007. Obvious and recognizable symptoms began slowly in 2008 and then I had several weeks of new symptoms early in 2009. My second doctor put me on Copaxone. I have had the most ghastly injection site reactions lasting at least three weeks with severe swelling, welting and extreme itching that lasts and lasts. I took C for about one month and could not tolerate the pain and swelling any further. Plus, my insurance company insisted I buy the meds from them. I could not because I had no one to sign for them and was not going to have the drugs come to my job. So currently, I am on nothing and am hoping for the oral drug, which I would be very willing to take. If Merck is going to have it available this year, then that’s a good thing and I’m hoping it will happen soon, 2009 is almost half over. Bless you all and good luck.
My wife was part of an intravenous Cladribine study for MS in the early 90s. I could tell she was getting the real drug, because she was weak the night after treatment and then better the rest of the week. I saw the improvement in her, and she had a nice plateau for years afterward, before resuming her downward trend. The MRIs showed reduced scaring in her brain. They considered the study a failure, however, because the improved MRIs (which were common) could not be correlated with concrete benefits. I feel this was because the measures they used were too subjective.
Anyway, though it is too late for my wife, I wanted to tell you the drug is well known, and well worth a try.
I’m ready for a change. I’ve been on ABC drugs and got to the point I said no more, With my past history I was put on scheduled solumedrol, steroids, and have done fairly well but have gained 40+lbs. Not good. I’ve been in a chair for the last 5 years and the extra lbs my transfers are getting harder. So happy to hear about this. Good deal!
2009 is about to go!
Still there is no update of cladribine/fingolimod.
How long they will take to get it approved???
I year back in Charleston, WV at Capital Neuro office my Sister, Mother, and my M.S. doctor met with one of the creators of the pill my mother and I are both on Copaxone and my sister is on Avonex and he asked how would we feel about it. I’m sorry anymore I would take nasty thing you could think of insted of a shot and getting the lumps the hardly ever go away. So that is how I feel about the oral Medication. The Creator we talked was very nice and wanted to know everything and that is so good so He wasn’t just a Doctor looking for another payday from Merec.
Crystal Carrmichaels
When any compound becomes a medication the timeline is aprox 15 yrs untill it is finally approved by FDA. These medications have been in clinical trials for more than say ‘two’ years. Patients who participate in clinical trials are helping to get/give more information to these compounds that will soon become medications. You can learn more about clinical trials, their phases, and the time it takes to develop these on http://www.clinicaltrials.gov.
Research will never stop as long as there is the fight for any cure
Happy Friday!
I have been on copaxone for aprox 7 years and I am ashamed to say I have not been that good with my shots over the last few years. I am however very lucky in the fact I do not have many symptoms “if any” and wish to keep it that way so I am praying for the oral form to come soon. This I know I would take daily with no hesitation. Tracy
So have they heard anything else on it??? Im in the works for being dignosed with MS and im really hoping they have something figured out soon..ill take a needle if i HAVE to…but i really dont want to….expecially EVERY DAY!! heck no!
I have been on Betaseron since it came out in 1993. Prior to that, I took steroids daily and used massive doses of Solumedrol during flare ups. After being on Betaseron, I was able to come off the steroids and just used oral steroids when I had a flair unless they weren’t effective, then I went on IV. Since 2002, I have had NO flair ups and even prior to that have had no changes on my MRI’s. I will continue the injections!
To Marie. All the distributers of the ABC and Rebif have Patient Assistance Programs. If you meet the financial criteria, they will pick up most of the cost of the med. I pay $50.00 a month for mine, and I have Medicare. Your neurologist should have the phone number, or you can go to the company’s website and look for the link to Patient Assistance Program for the phone nuumber.
To MS Researcher. When a drug is already approved for something else, the drug company applies for an extension of indications (diagnoses approved to be used for). Also, there is a process called “fast track” where if a drug has been proven effective and there have not been reports of severe side effects, it can be approved sooner, especially since there are no other drugs in this catagory. (I am an RN and my brother is a Research Chemist for a drug company, so I am familiar with this.)
the abcr drugs just make people sick, if the drug companies would just (but out) many more people with MS would be doing well, no cure they say, fine but there are better ways to help people with MS now they are control who can get certain testing and god forbid make sure we don’t get results. pharmaceutical companies are keeping people sick cause its millions of dollars in there overstretched pockets
@Nikki My first husband was 21 when he was diagnosed with MS. Three years later, he was in a wheel chair and then bedridden that same year! He was 39 years old when he died! Now, our youngest son has it at the age of 26! How long are you willing to watch your child die from the same thing that took his father! Don’t tell us whom have fought this monster for more than a decade how we need to wait…wait for yet another generation to suffer!