December 24, 2021 at 4:29 am #17871
As of October 2021, there were reports from the phase III ADAPT study that efgartigimod/Vyvgart was found to be effective for seronegative MG. Then on December 17, 2021, the FDA approved this medication only for AChR-positive patients. What happened?
I have seronegative generalized MG and am currently taking prednisone, loads of pyridostigmine/Mestinon, and methotrexate. I took Cellcept (10 months) and Imuran (22.5 months) but had to discontinue both due to side effects. For the past three years, in order to be somewhat functional, I have had to undergo routine plasma exchange. I am grateful that my insurance pays for the plex, and I have managed to stretch it to every two weeks, but I would prefer not to have to do it. Therefore, my neurologist and I were looking forward to FDA approval (and insurance coverage) for efgartigimod. Does anyone know if Argenx is planning to submit efgartigimod/Vyvgart for FDA approval for seronegative MG?
December 24, 2021 at 11:03 pm #17875Jennie MorrisParticipant
Me too. My neurologist has been looking forward to the approval for my treatment. I had read the previous press releases and it was submitted for all gMG patients. I’m seronegative and have had serious side effects from prednisone, imuran, cellcept, tacrolimus, IVIg, PLEX, and most recently, Rituxan. I’m out of options. Argenx website celebrates its approval for the most common form of gMG. What about the rest of us?
March 10, 2022 at 8:56 pm #18619Joe MrazParticipant
Today, March 10, 2022 I received an infusion of Vyvgart without any issues so far. I will get 3 more infusions one week apart. I still have the catheter for Plex in case the Vyvgart does not work. As far as I know the medication is FDA approved and supposedly Medicare approved. I have MG in the facial area for 4 years. Went through many Plex infusion which did help me immediately. However when I get the symptoms they arrive within days and I can not swallow food, water and talk little. My tongue gets lethargic and go quiet. During a flair up the mucus that suddenly accumulates in my mouth chokes me so I am careful drinking since all muscles in the mouth and throat fatigue fast. I had my thymus gland removed 6 years ago prior to any symptoms of MG.
March 10, 2022 at 9:05 pm #18620
I am guessing you are not seronegative, correct?
I hope you get the remarkable positive results they tout.
I’ve heard first or second infusion gets positive results.
keep us appraised please.
December 25, 2021 at 12:38 am #17876
I too was looking forward to the approval and my neuro thought it would get approved for us as well.
i meet with him on 1/10 hoping to get info.
I started IVIG 6 weeks ago hoping it to be a short term deal.
I wonder if the drug company felt the approval would get the best chance of approval this way and we seronegative people will have to get approval off label which is how IVIG is anyway.
we will see……
merry Christmas to all.
December 25, 2021 at 12:57 am #17878Amy CessinaParticipant
Doesn’t the drug work by clearing the auto antibodies to acetylcholine receptor. The obvious approval are acetylcholine positive. Then they have to study if it works for other types. Doctors can still use it off label just have to get approval from insurance.
January 1, 2022 at 2:47 am #17941
They actually included I think 27 people or so in the study and they had mostly positive results. But I agree they likely have to have an independent study with just seronegative. Hopefully we won’t be neglected as there not nearly as big a group of us. That’s why I wonder if they will just use it off label for us.
time will tell.
January 4, 2022 at 12:06 am #17964
Theresa and Jennie, it looks like we are all in the same boat. The problem with Vyvgart being prescribed off label, is that our health insurance almost certainly won’t pay for it. Especially if it is expensive, which I suspect it is.
Theresa, if you don’t mind, please post (or PM me) and let us know what your neurologist says at your January 10th appointment. My next neuro appointment is January 20th.
February 11, 2022 at 7:21 pm #18360
I have the option to go on vyvgart whenever I’m ready.
i speak to neuro again Monday.
I figure nothing to lose but 4 weeks.
im on Medicare and a BCBS supplement and he is confident he can push it through . It is Barrow’s institute so they have the systems and staff to make this sort of thing happen. I’ve had many occasions over the years where one doctors office could make a treatment happen when another could not. Not necessarily MG. Even getting IVIG is off label for seronegative.
so it can be done.
March 1, 2022 at 3:02 am #18546KarenParticipant
The mechanism of action is to block the FcRn (neonatal (formally fetal) receptor) which is needed to create IgG antibodies— almost all auto immune diseases result from production of IgG antibodies which erroneously target and interfere with the normal function of a receptor (such as the ACh receptor in MG). There is no reason to suggest it would not work in patients who are seronegative in whom PLEX works. The data submitted to the FDA showed a trend of improvement in the small number of seronegative patients included; however, statistical significance was not achieved. I’m not sure how to go about it, but we must petition the FDA to reconsider approving the drug as all current clinical studies have excluded seronegative patients; alternatively we could petition the drug company to perform a clinical trial in seronegative patients, but that is not cost-effective for them; therefore unlikely.
March 1, 2022 at 3:06 am #18547KarenParticipant
I’m not sure how to go about it, but we must petition the FDA to reconsider approving the drug as all current clinical studies have excluded seronegative patients; alternatively we could petition the drug company to perform a clinical trial in seronegative patients, but that is not cost-effective for them; therefore unlikely.
March 9, 2022 at 7:48 pm #18605
Or perhaps a class action law suit.
many attorneys out there?
may have to do each insurance company starting with Medicare for off label use. ?
January 21, 2022 at 11:04 pm #18110
I had my neuro appointment yesterday. My oral methotrexate dosage has been increased to 15mg. per week. Since he ordered bloodwork to check my immunoglobulin levels, I guess he is considering IVIG then subcutaneous IG if my antecubital veins continue being recalcitrant. Fingers crossed 🙂
February 11, 2022 at 8:15 pm #18361Gordon SaxtyParticipant
I would really like to reach out to this group to find out what is known about the non-responders to efgartigimod and nipocalimab.
In phase 3 efgartigimod works for 68% (great news) but 32% it does not in gMG
Likewise, in phase 2 nipocalimab works for 52% and 48% it does not.
On non-responders is their a high baseline of IgG or have neutralising antibodies to the therapy started? Or something else?
Any discussion greatly appreciated
March 9, 2022 at 9:08 pm #18607Wayne EisenParticipant
Hi Folks –
I wish I could get some Vyvgart!!
Kaiser will be doing its own pharmacy evaluation.
Best wishes, Wayne
March 10, 2022 at 2:30 pm #18614JennyParticipant
I keep hoping they announce an extended study for seronegative patients!
April 5, 2022 at 3:39 pm #18782Sheila TroianoParticipant
Anyone know if you have to undergo other treatments prior to starting Vygart to get it approved. I had to go off the imuran when I had COVID then was forced by my workplace to get the booster 3 wks after I had it. I can’t get back onto it. Everytime I restart, I get terrible vomiting without warning. Not really pleasant when a bathroom is far away and I work in healthcare. Do you need to try plasma or IVIG before they will approve Vygart?
April 5, 2022 at 3:40 pm #18783Sheila TroianoParticipant
Oh, also, I am antibody positive
April 5, 2022 at 4:34 pm #18784
I’m sure each insurance has its own protocol.
I would ask your doctor to prescribe it and see if you get coverage. Also contact Vyvgart yourself and ask how to get it. You can log into their site and it will tell you who to call. There is also grants through them to cover copay up to $25,000. I believe.
you are antibody positive so you qualify.
seronegative do not. I start in 10 days it took some work and not accepting the first denial to get it approved.
I got lucky.
Vyvgart definitely wants to get it to everyone and are very happy to help.
May 5, 2022 at 3:45 pm #19093MichaelParticipant
Here’s the saving grace for us seronegative folks, Imuran, Cellcept, Retuximab, IVIG and many other treatments are not FDA approved for MG and most are covered for use with most insurance companies.
May 12, 2022 at 10:14 pm #19146
I completed my 4th infusion of vyvgart last week.
about half way into the 2nd infusion, I began noticing subtle things. Less naps, forgetting mestinon.
Then 3rd and 4th infusion, those and other “subtle” changes.
after the 4th, the next day was a big improvement. Not like ready for a marathon, but gradual daily improvements. Much like the snowflake description of our disease. Not every day the same but of course the more I do, a couple days later I might get pretty tired. Much different though.
note when you have had the disease for 10 years, we naturally schedule our time so this habits don’t disappear immediately.
I am convinced there is a significant improvement. If it had to out a number to it, I would say I am 70-75% better, maybe a little more. Hardly any SOB, few and shorter naps.
I can go all day, sometimes till 11 pm.
I’ve been told that it can take 2 or even 3 cycles before a patient might experience improvement. But it is real.
I hope this becomes available to all Seronegative patients. It’s worth the opportunity.
‘absolutely no side effects.
down to 7.5 mg prednisone.
i have to remember that reduction will cause MG like symptoms.
good luck to all.
May 13, 2022 at 1:31 pm #19148MichaelParticipant
Hello Theresa, That’s fantastic news, glad the therapy seems to be working for you. Can you clarify “i have to remember that reduction will cause MG like symptoms.”? Are you saying you become symptomatic because of the taper, but it’s not the MG flaring? I’ve been in IG for a couple years. I’m down to 7mg a day, but am afraid to go further. Every time I taper, I have droopy eye symptoms, but a couple weeks later everything clears up.
May 13, 2022 at 6:39 pm #19149
Sorry, reduction of prednisone, causes bothe it’s own side effects, but also can cause flaringnof the autoimmune disease for which you are taking.
so yes, my eyelid has been real droopy with .5 reduction in spite of the VyVgart benefits.
I want off the prednisone so I have to keep that in my mind that it is quite possibly the steroid reduction and that the treatment is all good.
and overall it is.
daily I can see my activity level, fatigue, SOB symptoms are all better since that last infusion.
I am Seronegative so super excited it is working.
hope that clears up my explanation.
May 13, 2022 at 6:43 pm #19150
Mike just reread your comment.
i was reminded yesterday by a veteran MGer, she said to remember our eyelids have the smallest of nerves to control them and they are the most outlying. So it is natural they would respond Accordingly.
I have to jow drop .25-.5 mg every 3-4 weeks so my symptoms are not too profound. I find after 3-4 weeks they subside.
im at 7.5 mg right now. Down from 20 beginning in November.
it’s a slow haul. I have tons of side effects from them so want them gone. Just praying the VyVgart gets me there.
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