Relyvrio fails phase 3

[Nikki J]

Amylyx Pharmaceuticals Announces Topline Results From Global Phase 3 PHOENIX Trial of AMX0035 in ALS

- PHOENIX Study Did Not Meet Prespecified Primary or Secondary Endpoints - Data From 664-Participant Study Reinforce That AMX0035 is Generally Safe and Well-Tolerated - Within the Next Eight Weeks, Amylyx Will Continue to Engage With Regulatory Authorities and the ALS Community to Share Topline...

www.amylyx.com

As you know it was approved after a phase 2 on that data and also ole. It wasn’t conditional but there was an exchange during the ADCOMM where it was asked what if it fails phase 3? Amylyx didn’t outright say they would withdraw it but hinted and apparently they are now “considering” withdrawing it. I imagine insurance will no longer pay

 

[smarinkov]

While they shouldn't pay. The price was ridiculous in the first place. It would be only fair that they withdraw the drug. It would be also funny if in June we discover that TUDCA alone is however beneficial in some way. But I wouldn't hold my breath.

 

[lisa g]

They haven't pulled it yet, CVS CAREMARK called today to renew the prescription and still had it paid through insurance. I spoke with my neurologist this morning about the phase 3 failure. He wants to wait and see the whole report. I will say that my visit to clinic is every 6 months and my last appointment my ALS/FRS scoring went up 2 points. I can't say if the medication has anything to do with it, I always argue that the rating is based on interpretation and needs to be re-evaluated on the scoring process.

 

[Marieb425]

My husband has been on Relyvrio since it hit the market and he’s been in a continual decline (I guess ALS always is, but he was diagnosed 18 months ago and it seems to be relatively fast). We spoke to his neurologist and he said they were disappointed with the results and it’s reasonable to stop the medication.

 

[Nikki J]

MGH just sent an email. They said it is safe to stop but please reach out to your treating team to discuss. I do think insurance is going to stop paying pretty quickly even before it can be withdrawn.
I can understand wanting to see the full paper. I think Qalsody looked better when we saw all the data than it did from the topline. The relyvrio topline report sounds pretty grim though

 

[bwest10]

I tolerated it well for 8 months before a rise in my liver function tests. I also believe it was affecting my pancreas causing GI issues. I don't believe it was helping anyway. Not surprising it didn't pass Phase 3.

 

[Landis02]

My PALS stopped taking Relyvrio last Sept due to some unrelated medical issues. I have 3 plus boxes it (expires 5/31/24) if anyone wants it for free. I’ll pay the shipping cost. Message me.

 

[Nikki J]

Amylyx Pharmaceuticals Announces Formal Intention to Remove RELYVRIO®/ALBRIOZA™ from the Market; Provides Updates on Access to Therapy, Pipeline, Corporate Restructuring, and Strategy | Amylyx Pharmaceuticals, Inc.

- Based on topline results from the Phase 3 PHOENIX trial of AMX0035 in ALS, Amylyx has started a process with the FDA and Health Canada of voluntarily discontinuing the marketing authorizations for RELYVRIO/ALBRIOZA - RELYVRIO/ALBRIOZA will no longer be available for new patients as of today;

investors.amylyx.com

 

[Landis02]

Very sad. We all had such hopes that it might ease progression. I certainly hope a few PALS are seeing a benefit from it.

 

[Nikki J]

Yes. I do think this is the best ending they could make though. If someone wants to continue because they think it helps they will be able to with no insurance issues. I wonder how many will. A friend stopped a little reluctantly and found it had been suppressing her appetite ( and weight loss has been an issue)

 

[RinT]

Something they had failed to tell us when my PALS started on it was its very high salt content. Would have been good to know as she'd had a hospitalization for fluid on the lungs. Saw a steady and mysterious rise in her BP until one doctor kindly informed us of this and recommended she stop it, now BP is great.

 

[Firefighter58]

For those interested iam still alive and doing well, I am in a nursing home and that made life easier for my wife and my self. Like the last ten years I am confined to an electric wheelchair supplied by the als, I live a pretty normal life three meals a day a lot of activities to get involved with and expert care. I would recommend this lifestyle to anyone with als.

Al

 

[Loulou22]

Thank you for this insight Al. I am 18m post diagnosis limb onset and very little bulbar involvement so far, and my lungs are no different to before. I’ve been thinking that rather than burden my family and particularly my aging mum, that nursing home care may be my choice.

 

[Tomswife]

We stopped Relyvrio after 5 weeks or so. Terrible diarrhea, and Tom needed to use a hoyer lift to have a BM. I called and told them we were ending and they wanted me to give it more time. I asked how often and long were they capable of having a BM from a sling. ???

PS. you are all always in my thoughts and prayers. Kathy

 

[lisa g]

I'm curious just how many people that were taking Relyvrio decided to stay on it and have it sent for free by Amylyx?

I had started taking it before the FDA approved it having it made by a compounding pharmacy then once it was approved getting it from my specialty pharmacy

I thought that it was helping slow my progression but it could been a coincidence since I progressed slowly for the past 6 years. I made the decision to continue the drug and talked it over with my neurologist. He said that he would back my decision and said that he was finding that his patients were split down the middle from those that decided to stop the drug and those that decided to continue with the drug.

Lately I'm finding that I can no longer tolerate the medication. I even cut it to once a day but am finding that it is now making me dizzy and weak for about 2 hours after I have taken it and I get extremely congested afterwards. This is definitely affecting my quality of life so as of today I will no longer be taking it. I don't know why all of a sudden it's affecting me now this way when it didn't affect me this way before but it's enough for me to stop.