Mytelase discontinued in US
 

My housemate has Myasthenia Gravis. She was diagnosed in 1989. Several years ago when Prostigmin lost it's FDA approval, we switched to Mytelase. She has had excellent results taking Mytelase vs Mestinon and Prostigmin. We got word today that Sanofi has decided to discontinue the production and sale of Mytelase in the US. This will be devastating for my housemate. Our pharmacy has been able to track down a few bottles to get her by for a while, but eventually she will have to go back on Mestinon, which doesn't work well for her.

My question, is Mytelase discontinued worldwide? I know it has been popular in France and other parts of Europe. I would appreciate any info. Thanks!

Mike J

I read that yesterday too ... my daughter is on Mytelase because Mestinon didnt work fine for her :(

we're from Slovenia, Europe and get Mytelase from Sanofi,France ...

don't know what we're gonna do if she has to go to Mestinon :confused:
if I get any information from her nevro, I'll let you know:hug:

You might want to contact some Canadian pharmacies.

I read a letter online saying only in US?
https://docs.google.com/viewer?a=v&q...UstXC5Fw7Rverg

It is unclear to me if this means EVERYWHERE?
Have you called Sanofi here for details?
Tel: 800-981-2491

Thanks. I did check a few Canadian Online Pharmacies, but since their source is Sanofi US, Mytelase is listed as "not available".

Mytelase was never widely prescribed here. (I wish I knew why. It seems to be far superior to Mestinon.) Her Neurologist was not even aware of it when she asked about it. Her pharmacy has always had difficulty getting it.

From what I researched online, it appears Mytelase is discontinued in Australia, Germany and the US, but is still available from Sanofi France, Hungary, Czech Republic, Poland, Sweden and from Ifet in Greece. (I have no way to verify this nor do I know what Sanofi plans to do in the future.)

The FDA would allow us to purchase 90 day supplies for personal use from outside the US, but I have found no sellers that would provide it. (Still researching that possibility. Most "online pharmacies" only deal with popular and generic drugs.)

I discovered Mytelase a few years ago when Prostigmin lost it's FDA approval here in the US. (My housemate took Mestinon with Prostigmin at that time.) While Prostigmin is still available here, since it is no longer "FDA Approved" insurance won't pay for it. Researching the history of Prostigmin, I discovered that Mytelase was basically a better version of Prostigmin. It has definitely been good for my housemate.

We will make some calls today and I have plenty of e-mails out. I will report back as I learn more.

If Mytelase is an OLD drug...it was probably grandfathered into the FDA approval process. What the FDA does is go thru old drugs now, and require them to apply with new applications to show efficacy and safety. Guaifenesin for example and even levothyroxine had to go thru this process not to long ago.

When a drug doesn't have the consumer use base, to provide the incentive ($$$) drug companies drop the product instead of applying. The link to Canada and Australia suggests and FDA thing since they typically follow the FDA, here.

This sounds like a bummer for you. I certainly hope you find
what you need. I'd still call Sanofi to find where to go next. They might help you or tell you more.

Mytelase is old but it is fully approved and has been kept current, just like Mestinon. Prostigmin was grandfathered because it came to market before the FDA was founded. The FDA has a mandate to remove grandfathered drugs or have them go through the current approval process. This is why Prostigmin is no longer approved. It would cost more to go through the approval process than they would ever make back in sales.

Actually in the case of Guaifenesin, the original formula was approved, but the time-release version was not and faced removal. The first company that filed for it's approval got the exclusive rights to make it.

My housemate did talk to the Office of the Deputy CMO at Sanofi this morning. She is hoping for a call back from the Deputy CMO. She also found a Canadian Pharmacy that regularly imports from France. They are checking on Mytelase.

Mytelase
 

I've been on Mytelase for about 60 years (or however long it's been available). I called Sanofi and didn't get much help except that it is being discontinued. I dread the prospect of switching over to ? Mestinon?
I'll watch this board for any news or actions that can be taken. I really didn't know whether I was the only one that still used Mytelase.

mestinon vs mytelase
 

I do not do well on mytelase and have taken mestinon for over 40 yrs. The cost of mestinon is astronomical in the U.S. I wish I could take mytelase, 1/3 the cost. Good luck, I'm currently looking for help with the cost of mestinon.

Just for your information, Mestinon (brand, no generic) is sold here in France or in Belgium for 0.40 US$ per tablet...
Maurice.

I would try and find a French pharmacy to order from and hope it makes it through customs. Just don't order too large a quantity lest they think you're dealing something and I've heard they don't tend to stop people's personal meds. My guess is the worst that'll happen is they confiscate it and you're out the money you paid (don't quote me on that--I'm not a lawyer and don't want to get you sent to prison).

My dad has been on Mytelase for several years as well. It is quite a scary thought that he will have to go on Mestinon. He has tried Mestinon several times and it simply does not work for him.

We are searching for other alternatives. Will keep you posted.

Its a shame that they take known working drugs off the market, but do no research to replace them with better drugs.

Scared without Mytelase!
 

I have never posted anything online. But, I have been searching the internet for my mom. She has been taking Mytelase also for 60 years. She thought she was the only one. Two days ago she attempted to refill her prescription and was told Mytelase was discontinued. She feels she has only 40 days to live. Has anyone heard of EN101 or Physotigmine? Scared.

I am also on Mytelase. Fabulous drug, changed my life. I am so miserable on Mestinon. I was finally diagnosed with gluten intolerance and my pharmacist pointed out that Mestinon is a bromide and it agrivates my gluten intolerance. Since Mytelase is a chloride it does not bother me. I wonder why doctors don't offer Mytelase to their patients having gastro issues with Mestinon/

Not only did my issues clear up but the medication works so much better. None of that roller coaster up and down. It just works all the time. Wonderful stuff.

Okay. So the year supply Sanofi said was in the market is already used up. I did find a few bottles through Kmart a couple of months back You could try filling your prescription there.
At the time I got my bottle they had some bottles left in their warehouse. It's always been hard to get that medication in my area.

Luckily the medication is still being made in France. which means you can import the drug for your own personal use. I have investigated this. So far I have a verbal agreement from the FDA for an Investigational New Drug acception. (yeah, I know it's not new, it's a long story.) And I have a verbal agreement from Sanofi to accept the IND and import the medication.

Currently I am waiting for my doctor and the pharmacy department at the hospital he works for to submit the IND and get all the formal approvals. Government and paperwork, I don't have to tell you how long that is going to take.

My IND will only cover me. You will need to contact your doctor and ask him/her to submit an IND through the FDA on your behalf.

I don't understand why the Myasthenia Gravis foundation isn't helping on this. I tried to get some help from them. they told me to just switch to Mestinon. When I told them I could't take it they recommended Prostigmin. I told the woman the FDA made that drug illegal three years ago. And that was all the help I got.

I hope this helps you. I am only sorry I can't get a general IND for all the MG patients on this. I bet there aren't more then 20 of us in the US.

re:IND Mytelase
 

Your message regarding submitting an IND to have Mytelase imported is extremely interesting. I have referred my doctor's office to it. Perhaps you could expand on your efforts & give some help.
-Should each person having an IND application submitted talk to the FDA to get their verbal agreement to accept it? Is there a particular dept or person to contact?
-Should Sanofi be requested to accept any shipments? Would they hold it only for a certain person and/or pharmacy?
-If your application is accepted is there a possibility of getting a general idea of the language your doctor's office used in completing the application? This could be quite helpful to others in their filings.
Thank you for all your work, for sharing it and for giving some of us a ray of hope.
PS-I will speak to my local MG chapter & see if they can get the national foundation to help in this matter.

MG meds from UCLA research Neurology
 

I am taking Azathioprine 50 mg 4x per day. I also get IVIG infusions every 2 weeks. I'm in a research group at UCLA. My neuro at UCLA is getting me off prednisone which I was taking for several years along with mestinon. My neuro took me off mestinon. IVIG's are SO expensive but I have good insurance and am on SSDI and long term disability from my work (for 5 years). I'm 62 and started with occular issues at about 56. Had a severe crisis last year and ended up in hospital. That is when they started me on IVIG. It makes a huge difference - don't know if this is a possibility for you or any of the folks posted here. May we find a cure - in our lifetime! :grouphug:

Contacting MG Nat'l Foundation
 

I contacted the National MG Foundation today to see if they had made any response to Sanofi regarding the discontinuance of Mytelase. They have made no response and indicated that they have not heard from any Mytelase users expressing concern about the discontinuance. They took my information and noted my concern. I would urge other Mytelase users to call the foundation amd make their voices heard. Their phone number is 800-541-5454. I would also suggest that if you belong to a local MG Chapter to ask them to lend their support by contacting the National Foundation on our behalf.

I made my call. this time I was listened to.

I wonder if making a Facebook page asking Sanofi to save Mytelase for the few patients who need it might help. I worry about the elderly people who take it and are not wired enough to get help with their drug being taken away.

Canadian Pharmacy
 

Did you have any luck getting Mytelase from the Canadian pharmacy that imports from France?

Short answer? No. I tried that, can't be done.

Trying to get help elsewhere.

Mytelase HELP
 

Mytelase is my lifeline. I have been on the drug for 35 years since I was a kid and nothing else works. Mestinon has never worked well for me, nor Prostigmine. I realize there is no money in it for the drug companies because not enough people use it. But is there no recourse? Are those of us who rely on Mytelase to live supposed to suffer or die becasue a drug company doesn't have to manufacture it? We are not talking about aspirin here. It seems that folks on this blog can ban together to resolve this issue for all of us...at least until we die out. No one new needs to be put on this drug but until the last person expires there should be an obligation from the drug company to provide an essential medication. I wonder if this is a legal issue? I know I am not going to have any quality of life with out it. Hope others weigh in with possible options an/or recourses. Let's not give up.

How about all of us call or send letters to Valeant Pharmaceuticals, who has the Mestinon brand, to see if they can make a deal with Sanofi to take over the production of it.

I highly suggest this AND make sure they are specific and NICE.

http://www.sanofi.us/l/us/en/index.jsp

http://www.valeant.com/

These guys make "deals" all of the time.

Annie

Thank you very much for this information and for sharing your efforts here.

I am just beginning to work on this with my father, who is in need of Mytelase for his MG. We will also be following up with Sanofi directly and will share what we learn here.

The IMD may prove to be the most reliable avenue, so we look forward to hearing more about your effort, and perhaps we can work together on this.

I agree that the Myasthenia Gravis Foundation should get behind this effort with us and help facilitate this process. Let's continue to organize here and together perhaps we can have some leverage with the Foundation to request assistance with this effort.

As you express, there are others such as the elderly who are not able to advocate for themselves. Hopefully our efforts will benefit not only ourselves, but those and others who rely upon this medication. Uniting our efforts, may be the best way to insure access to this critical medicine for us all.

My dad would particularly appreciate any specific information about the IND process and how that is going.. We would be happy to collaborate on that or any other viable efforts. Is there anything we can do to help with that now? We are making this a top priority!

For any interested parties: please be in touch directly to collaborate on efforts including:
- Investigational New Drug Acception (IND)
- encouraging the Myasthenia Gravis foundation to assist us in obtaining Mytelase
- **
- possible effort to encourage another pharmaceutical company to take over production of Mytelase
- any other ideas for us to maintain access to this necessary drug

Hi Annie,
Did you have any luck contacting Sanofi and Valeant with this suggestion? It seems like a great idea. We (my dad and I) will certainly get behind this idea and help. Please share any progress thus far and let's be in touch. Perhaps if enough of us show interest, these companies will move forward on our behalf. Look forward to working together on this, and other ideas!

You make a good point. Maybe there is a legal issue and perhaps together we can investigate this question further. Does anybody happen to know more about the legalities of removing an essential medication from the marketplace?

Glad you were listened to! Can you tell us more about the call and what came out of it?

I agree that creating an online advocacy group ** is a good idea. In the meantime, let's continue to be active in this forum to share information.

Maybe we can submit a group request to the Myasthenia Gravis Foundation to act on our behalf. Maybe there is some legal remedy we can take with their help to insure our access to this necessary medication.

Let's keep working together here and pushing forward!

Great effort! Let's think about forming a group to contact Myasthenia Gravis foundation together. It seems that they should take our requests seriously regarding the Mytelase discontinuance and act on our collective behalf to address maintaining access to this necessary MG drug.

There is something I don't quite understand.

Isn't there a formal advocacy group for MG patients in the USA-the MGFA?

Why aren't they taking any action regarding this?

Patient's advocacy groups have influenced research, allocation of resources, approval of expensive medications etc.

Why can't the MGFA influence the decision to remove a form of treatment which is essential for some of its members?

It has been the experience of some neurologists and even suggested in the medical literature that mytelase is more effective and better tolerated than mestinon in MuSK MG patients.

Isn't that enough for the MGFA to take action?

Alice, I frankly doubt it is enough for the MGFA to take action. It doesn't sound as if they want to anyway.

Mytelase_Alliance, I didn't say I was doing anything. I haven't. I was hoping those of you who need the drug would do something. BTW, I don't do the "friend" thing, no offense.

Is there anyone who lives in CA who can meet with a representative of Valeant?

I have continued with my efforts to get Santofi to import Mytelase from France where it is still being made. I am asking for a group IND for everyone who needs it.

Today I received a call from Santofi. At 2pm today, January 22, 2013 they are meeting to try and find a way to import the drug for all the patients who need it.

So what do you need to to? CALL SANTOFI!!! 1-800-981-2491

They need your name. they need to know how many patients need the drug so they can import enough drug.

This is NOT a done deal. Your call saying you need the drug will help those in charge see there is a need for this drug.

So please get on the phone and add your name to the list. Or the name of your loved one.

You need to say you need Mytelase, it seems many people are on it because they are allergic to Bromides, so no mestinon. that is my problem.

And make sure you give your name and a contact number.


I probably made that as clear as mud. Ask if you have questions.

Needing help
 

---------
Hi ,
My name is Octavia and my Mother is in need of Mytelase. She is sure she will die without it. If anyone has been able to get some or if I should just follow the advice left on this forum can someone let me know. I need help. I'm scared I will lose her. Please feel free to send me and email with any info to help her. Thank you so much!

Octavia

I just phoned Sanofi's Medical Info Dept (3/05/13) and they said they would not import mytelase for customers. Have you had any further success with them to locate product? Thanks for any feedback.

I too called Sanofi last week (on or about 3/14/2013) and was informed they would not be taking steps to bring Mytelase into the US.

I then called the MG Foundation of America to again ask why they were taking no action to help in this matter-I got no response. So I then pulled up the Foundation's Federal Tax Form 990 (this is available to anyone on the internet) and it became pretty evident why there is no help from them. The MG Foundation farms all their operations out to a management firm-Kellen & Co.- and seems to have no permanent employees. It would appear that Kellen & Co. has no intrinsic interest in the MG community other than collecting their management fee. Certainly their actions-or lack thereof-would tend to support this conclusion.
A further inspection of the Form 990 (for the year 2011, the last year available) showed some interesting facts concerning the yearly MG National Walkathon Fundraising drive. In 2011 $418,000 was raised. Expenses related to the Walk were $276,000 of which $217,000 was paid to the EW Group for running the event, leaving $142,000 to benefit the MG community-or pay Kellen & Co's management fee. In other words for every $1 raised 34 cents went to the MG Foundation and 66 cents went for expenses. A pretty good deal for somebody-you figure out who.

Basically, we have no advocates in this fight

I am going to speak to the MG Chapter to which I belong to urge them to take a closer look at the National Foundation and their activities.

well that explains alot. the MG foundation has seemed pretty scammy for a while.

I did hear from Santofi and they say it's just going to be so terribly expensive to bring the drug in. In other words we are screwed.

And the corporations make even more money. Sigh.

Mytelase Found???
 

I appreciate all the posts. I am still desperately trying to find Mytelase. Whoever said Mestinon is more expensive in the U.S. has it backwards. Mytelase is much more expensive and now unavailable from Sanofi. I can't give up the fight since I am on my last two bottles and can't function without Mytelase. Can't we force the FDA to make them manufacture enough to support the folks who are still alive and using the drug? Does anyone have new information? Thanks much. ECJ

I have no new information. And frankly I think that is the last Mytelase you will ever see. I am told you can have friends or family purchase it for you in France and bring it into the US for your personal use. I don't think anyone here will be rich enough to make that happen.

there is no way to force them to make Mytelase. They can stop making it for any reason. There really is nothing more we can do.

I am begining to wonder if our time wouldn't be better spent trying to bring Monarsen in early. It is in stage two testing in the UK. My doctor seems to think it should work for me.

So, does anyone have any information on bringing a drug undergoing testing into the US early?

I have the final word. There will be no more Mytelase in the US. It is still being made in France and you can import it for your own use.

I am sorry. The people I talked to did want to provide it. they were very nice and I greatly appreciate all the work they put in on this. In the end it costs to much to make for the few people who take it.

So there is no more Mytelase.

So another thought. Has anyone tried contacting their Senator to see if there is something that can be done that way? I really hate to just give up on this. There just has to be a way to make this medication for those who need it.

It shouldn't be so hard to import it from one of the countries that still make it.

Mytelase is sold in french drugstores only by prescription.
Would it be possible for one US or canadian MG association to contact a french or belgian drug wholesaler and to import them?
Maybe this could be banned by USDA? There might also be high import taxes?
For your info, the full selling price in France is about 8 (eight) US$ per box of 50...
Maurice.