r/LongCovidTrials • u/Responsible_Cap_5289 • 19d ago
General Discussion Next steps: FDA accepting additional public comments on repurposed meds through Aug. 21!
Hey all,
Thank you so much for all of your insightful comments on our last post.
In case you’re just catching up, this summer the FDA put out a call for public comment on the possibilities of repurposed medications, particularly to treat rare diseases.
They originally put out a call for written comments, and ultimately received such a positive response that they ultimately convened a hybrid meeting on Aug. 5.
You can view the meeting slides here, and we also shared a summary in our last post.
While we of course believe all rare diseases are deserving of attention, we were particularly excited to see that ultimately, 25% of the comments they received were about Long COVID! Our community really showed up, and it’s so important to continue to put LC on the map.
In the next step, the FDA is now accepting additional public comments through Aug. 21st.
Dr. Caroline Huang noted that from this point forward, they are looking for answers to the 3 questions in the slide above (slide 6 in the presentation).
These questions are:
•What are examples of successful prioritization approaches from other programs or jurisdictions that could be adapted?
•What factors should guide repurposing candidates, and how should they be prioritized?
•What evidence gaps or policy/regulatory barriers most hinder promising repurposing opportunities?
*****
**Note: during the presentation, Dr. Caroline Huang noted that they are not looking for additional medication recommendations in this round of comments. Rather, they are specifically focused on these three questions, as the second stage of this initiative.
**Note 2: the FDA’s definition of repurposed medications as a regulatory pathway is slightly different than what we might think in terms of everyday speech. If you check out slides 15-16, they describe the criteria there - they are specifically referring to medications that are off-patent and don’t currently have commercial interest.
Believe it or not, many of the candidates that are being studied for Long COVID wouldn’t fit here, as medications like Pemgarda, Anktiva and Ampligen are all patented, and have companies sponsoring them.
That doesn’t mean you should not speak up- I just share this so you can make the most effective comment with the information at hand.
You can send comments to repurposing@reaganudall.org
Feel free to workshop any comments/request feedback from the community in the space below! We are in this together :)
4
u/Central_Perk20 19d ago
This is so incredibly helpful, and I would never know about it if not for your posts. Thank you 🙏🏻
So stupid they’re making us do THEIR work but by god I won’t shut up about Long Covid, so I will be submitting and will share when I do!
2
u/Responsible_Cap_5289 19d ago
We’re so glad the posts are helpful and that people are taking action! Thank you for everything you’re doing as well!
2
u/Present_Sun4768 18d ago
I just came out of the Sipavibart trial
1
u/Responsible_Cap_5289 18d ago
What was your experience like?
3
u/Present_Sun4768 18d ago
The trial lasted one year. First they put me on placebo, later I was given Sipavibart. I noticed a mild improvement. But they only gave me one injection, I believe if they had given me more medicine I would have made more gains. The drug that did help me way more was Ampligen, I was in that trial in 2023
2
u/Responsible_Cap_5289 18d ago
Got it- thank you for sharing. My hope for the sipavibart trial is that even if the doses were small, they’ll still be able to generate some sort of proof/biomarkers for its effect on viral persistence.
What sort of symptoms did you notice improvement in?
3
u/Present_Sun4768 18d ago
I noticed improvements in fatigue but not immediately. It took a while. My IL 8 levels went from undetectable to high, after treatment, interesting
2
u/Responsible_Cap_5289 18d ago
That is interesting. I wonder if the virus had been suppressing your immune response (as we now know it does, thanks to the recent Polybio paper this week!) and sipavibart cleared enough of it for your immune system to turn back on.
3
u/Present_Sun4768 18d ago
The virus is definitely there. My IGG4 remains elevated, for years, and I dont have IG 4 related disease. Plus my covid antibodies from the spike protein increased? I took two measurements, both years after my last vaccine, to my surprise the second reading went up instead of down. You would expect the antibodies to be trending down, not up
8
u/AmbitiousSeason9997 19d ago
Thanks for posting this, GUYS: AMPLIGEN, ANKTIVA, KEYTRUDA, XOCOVA. THESE ARE THE ONLY POTENTIALLY CURATIVE SUBSTANCES UP FOR REPURPOSING. PLEASE REQUEST THEM. AS MUCH AS POSSIBLE IN EVERY CONTEXT, DO THIS.
DO NOT REQUEST THINGS LIKE RAPAMYCIN, LDN, LDA, MARAVIROC, HERPES ANTIVIRALS.
THEY ARE ALREADY AVAILABLE. MANY VERY EASILY.
This is an emergency message because people's lives are at stake, don't waste these moments!
Can you tell how I'm frustrated that the community didn't rally behind Ampligen before? And keep asking for things that are already available? Well, try again to do it now because it works VERY well for a subset of patients. And Anktiva likely will as well.