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First oral MS DMD approved in US
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First oral MS DMD approved in US

Anybody see that the FDA approved Gilenya (FTY720/fingolimod)?

http://www.medicalnewstoday.com/articles/202109.php

http://www.nytimes.com/2010/09/23/business/23novartis.html

http://www.novartis.com/newsroom/media-releases/en/2010/1445917.shtml

I don't see anything yet about how soon it will be available, though.

sho
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28 Comments Post a Comment
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1396846_tn?1332463110
No haven't seen anything about it but I will check it out. Thanks for the update :)

Paula
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338416_tn?1413581329
Great!  It's not on the Aetna website yet.  I don't know if I can get it prescribed for me and paid for by Aetna, if it's not on their website... argh.

But I've just had to dump copaxone, and now we're talking about Betaseron.  If I can start taking the oral, that would be fantastic.
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Avatar_f_tn
Yes I just saw it on news. My understanding is.its available now. Maybe I misunderstood though.
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559187_tn?1330786456
My doctor was very excited about it but said he probably won't be writing scripts for it till December or January.  Exciting news for sure.

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900662_tn?1380159390
GREAT ....

I  Hope it lives up to  the trials.


John
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572651_tn?1333939396
It certainly is a new day dawning in MS treatment.  But before we get too excited we really need to understand the risks involved with this drug and make an informed decision rather than just jumping from injectibles to the pill treatment.  

From  http://www.webmd.com/multiple-sclerosis/news/20100922/gilenya-first-oral-ms-drug-gets-fda-nod?ecd=wnl_nal_092210  is this overview.....


"Sept. 22, 2010 -- The FDA today approved Novartis' Gilenya, the first oral drug for multiple sclerosis (MS). Gilenya (formerly spelled Gilenia, generic name fingolimod) last June received the overwhelming approval of an FDA expert advisory panel.

Gilenya treats the relapsing form of MS. The drug significantly reduces MS attacks. However, it has serious side effects, with possible heart, lung, and eye toxicity and increased risk of infection. Patients must be closely monitored, and regular eye exams are advised.

In MS, white blood cells attack the myelin sheaths that protect nerve cells. Gilenya, the first drug in its class, keeps white blood cells penned up in lymph nodes by taking away the chemical key they need to unlock the lymph node door.

Fewer white blood cells mean fewer MS attacks. But it also means less protection against infections. Novartis will set up a careful program for educating and monitoring patients taking the drug. Moreover, the company will continue long-term studies to look for side effects that may occur with longer-term use.

Gilenya was invented as a new way to prevent rejection in kidney transplant patients. But at the necessary dosage, the drug was far too toxic. The dose that would be used to treat MS is five times lower than the lowest dose tested in the transplant studies.

Even at this dosage, Gilenya can have severe toxicity. In clinical trials, side effects linked to Gilenya included:

Elevated liver enzymes
Macular edema (swelling of the central portion of the retina, causing distorted vision)
Elevated blood pressure
Shortness of breath
Bronchitis
Diarrhea
Bradycardia (slowing of the heartbeat, seen only upon first treatment. The FDA panel recommended that patients be required to receive their first dose under medical supervision).

Two fatal herpes infections occurred in MS patients treated with Gilenya at 2.5 times the 0.5-milligram dose for which Novartis is seeking approval.

But overall, the drug's benefits outweighed its risks among the more than 2,600 MS patients who took the drug in clinical trials."




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Avatar_f_tn
"sever toxicity". Well isn't that just bl**dy marvellous?

*adds another drug to her list of 'don't go there'*

Jemm. The skeptic.
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572651_tn?1333939396
http://nationalmssociety.org/news/news-detail/index.aspx?nid=3871  has their release here.

The point on my posting this information is to remind everyone that even though a pill may be simpler to take, it is still a drug with potential ill effects.  

If the injectibles didn't work for me, I would certainly be open to trying Tysabri or Gilenya.  Sirtting back and doing nothing out of concern for the side effects is not an option for me.  
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987762_tn?1331031553
I thought the white blood cell connection was interesting, though slightly confused by it. If the white blood cells are such a relevance (ie white blood cells attack the myelin and fewer white blood cells means fewer MS attacks) then wouldn't a persons white blood cell count be high during attacks?

It seems reasonable to conclude but i've been under the impression that there is no blood markers with MS, out of interest has anyone had a blood test during an attack? The only blood tests i've had during the hug, have shown high or excessively high WCC, apart from being told my immune system is either sluggish or its fighting a pretty big infection, it didn't really mean much.

I do still find it interesting, that i can have an obvious neighbourhood bug, and i feel brighter and more energetic instead of feeling worse than normal but about 10 to 14 days later when the bugs gone, I feel like i've been hit with a mack truck because all the MS like symptoms are having a party. Its just interesting lol.

BTW Jemm if you only look at the side effects of drugs, any drugs, then you wouldn't take anything, so please dont be put off too much. If your fully aware of the benefits and the side effects and are being vigilent, many of the MSer drugs could significantly change your quality of life, sometimes just the chance of improvement is worth the risks. :-)

Cheers........JJ  

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338416_tn?1413581329
This drug seems to have better stats when it comes to reducing disability and even encouraging new neuron growth.  Copaxone and Betaseron are only 30% successful.  I think I remember reading somewhere that your average drug trial may be off by as much as 30%.  So I've always wondered how effective these drugs really are.  
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147426_tn?1317269232
JJ - With regard to the "white blood cell" thing.  The type of WBCs being spoken about here are lymphocytes.  The kind of infections which raise the WBC count are generally bacterial and this involves the neutrophils.

The discussion is about "inflammation" and not "infection".  Conditions with high inflammation do not raise the white blood cell count in the peripheral blood.

The inflammation in MS is sequestered in the central nervous system which is separated from the rest of the body by the Blood-Brain Barrier.  So, inflammation in the brain is typically not reflected in any change in the peripheral blood cell counts.

Yes, they have taken blood in every imaginable phase of MS looking for reliable markers.  So far, there are none that have stood up.

Hallelujah for the new release.  I think my neuro had this in mind when he spoke about placing me on orals.

JEMM - The potential for severe toxicity exists all around us.  To put it in perspective you have to balance the potential of disability which is nearly 100% in most of us.  If you spend your life avoiding all risk, then you end up accepting what is happening to you as preferable, no?

I look at it this way.  I feel I need to consider the risk that I won't be able to walk in 10 years.  That risk is probably about 1 in 2.  Place that against the 1 in 1000 risk of PML in using a med like Tysabri.  For me it's a No-Brainer.

Quix
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Avatar_f_tn
Quix, yeah I fully understand that. I'm just such a chicken, and me and other family members ahve had such awful reactions to so many drugs, right down to anaphylaxis, that I am (obviously) paranoid.

The 30% effectiveness of Copaxone and Betaseron is 70% ineffective in my "glass 2/3s empty" brain (rather than 1/3 full).......

My MS nurse is going through things slowly with me, and supportive of any choice I make, whether it is DMDs or nothing or someting in between.

I can't even have something as old and basic as Stemetil without haivng the most violent whole-body spasms lasting about 3 hours after one tablet.........so when I read some of the really NASTY sideeffects these drugs can have, I hardly jump for joy.

Some of the only things I've had which have zero nasty effects on me are paracetamol (can't have Codeine, even 5mg and I have a seizure), valium (YES!) and some anti-reflux drugs.

Anyway, each to his own....
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987762_tn?1331031553
Thanks Quix for clearing up my WBC confusion, i was discombobulated by the reference to WBC, lol I've got a bug (infection on my brain oops not literally lol) and always get sicker after its gone, so not looking forward to the after affects, i'd rather keep the runny nose and soar throat.

Every step in the forward direction is a bonus, hope the oral drugs gain momentum and give more..........everything!!

Cheers.......JJ
  
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Avatar_m_tn
I think I would be very hesitant about taking the oral DMD as the list of side effects are all things I already have trouble with. But at the same time I really don't think I could ever do the injection type either. I am very allergic to bee and wasp stings and am suppose to carry an EpiPen with me at all times ( can be dead within 30 minutes from a sting if I don't get medical help ) but I don't. Mainly because even when I have been stung I have never been able to give myself the shot.  I don't mind getting shots ( and usually don't even feel them ) I just can't bring myself to give myself a shot.

Dennis
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1253197_tn?1331212710
Very interesting timing for me as I hope that I will be starting my oral drug trial in 2 weeks time. My Conultant says that the make up of ACT-128800 is very similar to Fingolimod and certainly all the listed potential side effects are almost identical so my feeling is that it is just another brand which will hopefully be licensed in UK in the future.

I will be posting regular journal updates once I start the drug trial and any side effects that I think I feel. Although of course I will never know if I am on the placebo or actual drug so watch this space....

It would be really interesting if anyone on the forum starts taking Fingolimod was able to keep a journal as I am sure this would be of interest to other people who may be interested in taking it. Of course how we all react to a drug is individual to us and our own bodies.

Sarah
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198419_tn?1360245956
This is an excellent interp and educational lesson for us Doc Q. Thank you so much.

And thanks, Sho for posting it.
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738075_tn?1330579444
As a Tysabri user, I'd love to see a risk/benefit analysis between Tysabri and Gilenya.  At this point, I don't know what to do.  My neuro was talking about switching me to Gilenya, or waiting for the Cladribine derivative.  
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649926_tn?1297661380
I am very excited about the oral med and just MS research moving forward!

My MS specialist at the Cleveland Clinic said that she won't use it until her patients have not done well on the already established injections with tons of data and history.

I have only done Copaxone and Avonex so I guess I will watch the news for scoop as droves of other MS'ers try it and see how they do.

A pill would be so nice instead of needles though - hardly reason to bug my doctor -
Thanks for the update Sho & Doc Q
Hugs,
Erin :)
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1045086_tn?1332130022
Michelleric and I went to a Moving Forward program less than two weeks ago that was put on by the Buckeye Chapter of the NMSS.  It was held at the MS Clinic where I'm treated and the medical presentation was done by my MS specialist.

He echoed Erin's neuro, stating that he thought the protocol for use would be that patients considered for treatment with the new oral drugs would be those who had already failed treatment with the established injectable drugs.  He also mentioned the doctors he knows who treat MS tend to be more cautious these days since they remember with heavy hearts patients they had hoped to help with Tysabri.  He prefers to take an observational stance for a while in cases where that's possible.

Mary
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429700_tn?1308011423
I don't think I can take any of the new medicines that lower the immune system.  I respond to the Mantoux test for TB.  I get a huge welt on my arm whenever I get this test.  

I would rather be alive and in a wheelchair than be spreading TB around and it killing me dead.  Does anyone know if this is a potential side effect of people in the study or on Tysabri that's been exposed to TB but inactive?  There's not much of a chance of me ever developing TB under normal circumstances, but I wonder if these drugs lower the immune system to the point of developing it and killing me dead . . .  Anyone know?

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1045086_tn?1332130022
Having a positive Mantoux test only means that you have developed antibodies to the TB bacillus.  It doesn't mean you have TB.  It doesn't mean you had TB in the past.  It doesn't mean you can infect anyone else with TB.  It doesn't mean you are more likely to have TB in the future.

Having a positive Mantoux test means you must have a chest x-ray to be screened for TB when other people get a skin test.  You also should NOT allow anyone to give you another TB skin test.  Once the test is positive, it will always be positive.   This test is not used for diagnosis.  It is used only for screening and once you have had a positive test it is useless as a screening tool for you.

Death from TB in developed countries is no longer common.  In today's world we have more to fear from bacteria named MRSA and VRE that can cause massive infections in almost any organ.

The  present injectable disease modifying drugs used in MS are immune modulators.  That means they reduce the hyperactivity of the immune system without suppressing it.  MSers using these drugs can still fight infections just fine.  The goal is to keep ourselves out of hyper-drive so we don't attack our own myelin.

It sounds like these pills have the same goal in mind.  They just might accomplish it in a different way.  I hope this puts your mind at ease a little.  I'm also hoping you have a treatment that is already working for you and don't have to think about switching for a long time yet.  That will give you time to see just how good these new treatments are.

Mary
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429700_tn?1308011423
Mary, please see the new thread I posted.  I don't think it would be appropriate of me to respond to this very encouraging news about a new medicine on this thread.

Thank you so much for helping me!  I am still very, very conflicted though!  I wish it wasn't so, but have had years of storing up information (which may have holes in it)  

I hope you or someone can put my mind at rest!

Thanks,
Debbie
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333672_tn?1273796389
Just to put a damper on this discussion, it turns out that Novartis is going to charge $48,000/year for Gilenya!

http://www.bloomberg.com/news/2010-09-30/novartis-gilenya-ms-pill-to-cost-48-000-a-year-update1-.html

Deb: I don't know anything about Gilenya or immunosuppressants and TB--you would need to talk to your doctor about that--but Gilenya is an immunosuppressant and not an immunomodulatory drug. The two people who died in the trial (on a higher dose than the one that was approved) died from infections that their bodies couldn't fight off (one was apparently also taking steroids which exacerbated the problem).

Basically, there's a real trade-off in that the newer drugs are both supposedly more effective than the current DMDs and more dangerous.

sho
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Avatar_m_tn
I have been on Gilenya for 2 years  and not 1 relapse when before I had them every 12 to 18 months
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1831849_tn?1383231992
AKAK - Welcome to our little group.

I'm happy to hear that Gilenya is doing the job for you! It's amazing how much progress they are making. Two years ago Gilenya was the first and only oral DMD. Less than 2 years later along comes #2, Tecfidera!

Kyle
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1981227_tn?1336332038
I'm thinking about switching to Gilenya in the future, it seems it is more effective than the CRAPs... Thanks for updating us on your experience :)
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5112396_tn?1378021583
I agree. Gilenya; more effective than a case of the runs. ;P
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5538989_tn?1412826714
Thanks for providing feedback as I am considering changing to Tecfidera and until one of the posters told me, I was unaware that there are 2 other orals out there. I will have to research Tecfidera vs Gilenya!

Hope you are doing well!

L
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