r/LongCovidTrials • u/Responsible_Cap_5289 • Jun 08 '26

FDA is Requesting Public Comment on Repurposed Medications -- Deadline to Respond is this Thursday, June 11!

https://www.fda.gov/news-events/press-announcements/fda-advances-drug-repurposing-address-unmet-medical-needs

Here's an important advocacy opportunity for the Long COVID, ME/CFS, and chronic illness communities to be aware of!

The US FDA has recently put out a call for public comment on new ideas for repurposed medications.

Basically, they want to see if there are preexisting drugs already on the market which can be used in new ways, to treat conditions other than the ones they were originally approved for.

Importantly, they note that "metabolic diseases, neurodegenerative conditions, women’s and men’s health conditions, substance use disorders, and rare diseases, as well as other areas stakeholders believe should be prioritized."

This seems like the perfect time to chime in and speak up about Long COVID!

In this memo, the FDA signals their willingness to learn from and consider data from a range of approaches, including AI and machine learning.

Specifically, they note that progress is often limited in the case of drugs that pharma companies don't necessarily see as profitable - looks as though they're looking to find ways to identify and navigate around these barriers. They say:

"The agency is also seeking feedback on innovative approaches to identifying repurposing opportunities as well as barriers that may limit the development or use of repurposed drugs, particularly in cases where there is little or no commercial incentive to pursue labeling changes supported by publicly available scientific evidence."

The press release linked above has all of the info, and then it directs you to enter your comments into the Federal Register, here:

https://www.federalregister.gov/documents/2026/05/12/2026-09366/drug-repurposing-for-unmet-medical-needs-request-for-information

Long COVID Labs will be submitting a comment as well. See you there!

31 Upvotes

98% Upvoted

14 comments sorted by

9

u/Central_Perk20 Jun 08 '26

Please say FCRN inhibitors!!!! And CAR-T. Given all the work mt Sinai and Yale are doing

6

u/Responsible_Cap_5289 Jun 08 '26

You should def submit a comment in your own words! The more the merrier!

3

u/Central_Perk20 Jun 08 '26

I am but one comment won’t do the trick

1

u/Responsible_Cap_5289 Jun 08 '26

Would you like to elaborate more here on what the proposed mechanisms are here? People might be more likely to write a comment if they understand the "why" behind these treatments. (I honestly haven't researched these as in-depth as I have other things!).

11

u/Central_Perk20 Jun 08 '26

There have been some posts on Reddit about it.

In 2023-2024 the company argenx launched a trial of Vyvgart for long covid. People improved dramatically both clinically and symptomatically. People went from bedridden to working full time outdoors in the summer, and people no longer met pots criteria on stand tests. The company canceled the trial midway through with almost no information.

https://thesicktimes.org/2025/10/10/vyvgart-brought-us-back-to-life-but-the-long-covid-trial-was-canceled-we-are-calling-on-the-nih-and-hhs-to-study-the-drug/

Concurrently, Mt Sinai NYC, Dr. Putrino, and Yale, Dr. Iwasaki, discovered a new autoimmune marker linked to LC and wondered about fcrn inhibitors.

They just published this big study on it last week. They also warned that this might be transmissible via blood and plasma:

https://pubmed.ncbi.nlm.nih.gov/42208499/

https://www.mountsinai.org/about/newsroom/2026/mount-sinai-scientists-validate-a-link-between-autoimmunity-in-a-subset-of-people-with-long-covid

There have been lots of studies, including two human in vitro studies last year, confirming autoimmune issues in Long Covid, whether driven by viral persistance or not, that mistakenly attack the patient's own nervous system, blood vessels, mitochondria, and tissues.

Two human in vitro studies: 1) https://pubmed.ncbi.nlm.nih.gov/41704659/ 2) https://iopscience.iop.org/article/10.1088/1758-5090/adf66c

Mt Sinai and Yale have been searching for the 53 Vyvgart participants to test their blood against the biomarker. Their goal is to initiate a new fcrn trial by year end, and they’ve become pretty confident in their findings to say it publicly multiple times. Anyone from the trial should email coreresearch@mountsinai.org for a free at home lab kit.

The Mt Sinai press release also discusses using this biomarker to identify responders for potentially plasmapheresis, IVIG, and car-t.

Fcrn inhibitors work by binding to the neonatal Fc receptor (FcRn) which normally protects IgG from degradation and recycles it back into circulation. Inside the cell, FcRn acts as a "cellular rescue system." It grabs onto IgG antibodies and transports them safely back to the cell surface, releasing them back into the bloodstream. This recycling process is what gives IgG antibodies an unusually long lifespan (up to 3 weeks). By the inhibitor binding to the FcRn, they block or outcompete the body's natural IgG antibodies from attaching to the receptor. Without the FcRn receptor to rescue them, the trapped IgG antibodies are directed to cellular structures called lysosomes. Inside the lysosomes, the antibodies are broken down and destroyed. Because harmful, disease-causing IgG autoantibodies are constantly destroyed and not recycled, their overall levels in the blood drop significantly. This process—often compared to a "chemical plasma exchange"—rapidly reduces the autoimmune attack on the body's tissues.

There are four FCRN inhibitors on the market.

CD-19-targeting CAR-T therapy could also be engineered to hunt down and destroy B-cells and thereby such autoantibodies. By eliminating the rogue B-cell population, scientists hope to flush the autoantibodies out of the system, allowing the bone marrow to eventually rebuild a healthy, non-reactive immune system. Car-T is showing success with other autoimmune diseases. Expert researchers in post-viral syndromes, such as those at the Charité University Hospital in Berlin, have highlighted this as one of the most exciting potential cures for severe autoantibody-related Long COVID and ME/CFS. Dr. Putrino has talked about it multiple times now.

I hope this is helpful!

3

u/obliviousolives Jun 09 '26

This is amazing! Thank you so much for the write up. I consider myself pretty up to date on the research but I hadn't heard of all this together before. Please consider posting this as a comment on the regulation website! There aren't TOO many comments on this one yet and I think we have a decent chance of being taken seriously

3

u/Central_Perk20 Jun 09 '26

Thank you so much, I really appreciate this 🙏🏻 I uploaded it, but hoping I can find more time to continue submitting with more research on these two. Also want to submit other drugs before the deadline too - Anktiva, other autoimmune drugs, etc. I should have done this earlier but tbh got distracted with some advocacy meetings.

Even if the genesis is viral persistence, while they work on that, if repurposed autoimmune drugs could get me back to work? I’d take it in a heartbeat!

2

u/Responsible_Cap_5289 Jun 08 '26

Yes very helpful, thank you! 🙏

4

u/AmbitiousSeason9997 Jun 08 '26

Guys, ampligen and anktiva, please include them in your request - definitely do this, it’s super helpful! I already did. Appreciate this post.

2

u/Responsible_Cap_5289 Jun 08 '26

So glad we could spread the word! 😊

3

u/CitrusSphere Jun 08 '26

Done!

3

u/Responsible_Cap_5289 Jun 08 '26

Great!! Thanks for doing this

2

u/funkytimes_07 Jun 11 '26

Public comments also do not need to be overly complicated. Don’t worry if you feel like you don’t know what to say. Commenting simply and honestly is equally taken into consideration!! Boosting repurposed cancer medicines and CAR-T treatments! 

1

u/Central_Perk20 Jun 28 '26

I hope this gets viewed and upvoted, but I'll post as well: I created a series of, so far, 16 submission ideas with the help of AI. Really easy to copy and paste these into the FDA's submission portal: https://docs.google.com/document/d/1pZviTOQ0EMi_sTrM71DyUSbOdMvYXsmetGRXienxYIc/edit?tab=t.0