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Would Any Support Team Members Be Willing To Email The FDA?

A MyPrurigoTeam Member asked a question 💭
Tooele, UT

I have exhausted all avenues to find out when the FDA is going to approve the new drug Nemolizumab to the thousands of us suffering from this horrific disease as I have been dealing w/this on my scalp for 15 years. I looked up their website & found their email & have decided I am going to contact them whether they will reply or not, before I go totally insane as it has totally affected my quality of life! I am a fossil & would like to somewhat enjoy the last chapter of my life with some… read more

April 22
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A MyPrurigoTeam Member

OMG, Deb thx for all that great informative research you did as I still haven't got around to sending an email, & to think I thought it would make them hurry the hell up for us thousands or more sufferers! Was in desperation mode, UGH! Well, guess decapitation or getting scalped is the only way I am only going to find some much-needed relief as I believe I will be in a mental ward sooner than later, JK, kind of, but at least I am not getting my hopes up any longer cuz guess I have been playing the victim role! With being diagnosed with PTSD and OCD & then this I am bonkers! I had a feeling that the timeframes I read during my research were probably just "Fake News" like everything else now in this crazy arse world! So screw it as the only lil' bit of relief I can get is from my antianxiety med which is only allowed 2 a day, bag of frozen peas (aka ice pack), OD on medicinal MJ (LOL), and the dreaded Benadryl which makes fossils onset of Bidenism faster, LOL! So Plan B, move to Japan, buwahahaha! My g-son was stationed in Japan awhile back so that would have been a very good reason for me to have visited him besides seeing him! Just what young g-sons want their ol' grannies w/'em! So, I hope the other team members read your post & not waste their time! I bet if those peeps doing the studies if they had this would make sure this was a priority! I mean no one understands how debilitating this horrific crap can be unless they have it! I doubt the older Derma I had (15 years ago) when I was in the beginning stages of Shingles, who gave me the ineffective vaccine which I am almost positive as one month later had what he guessed my first over the top itch-scratch spot on scalp as Eczema is what whacked out my immunology and neurological system! Luckily, when I go to sleep my nerves must also be asleep as it does not wake me up, so going to become the new Rip Vanwinkle Trans (oops), &/or Sleeping Beauty which is a farce cuz if there was any beauty it's gone, gone as being a real fossil! Sorry, I am babbling on, and on but wouldn't you know it if it wasn't for bad luck, I wouldn't have any luck at all! Wah, cry 😢 me a river, hee, hee! Thank you so very much Deb as ub the best! May God bless us all!🙏

April 22
A MyPrurigoTeam Member

Morning, i’m a mvery sensitive person instead of medicine helping me it actually has caused me more problems. , I found magnesium or anything natural that calms nerves helps my PN. Relaxing with positive thoughts in a bath of epson salts helps me. If you live near the ocean & the water is safe that has also helped. . I’ve had healing with kenalog shots directly in the nodules. Tiger balm, Emu-blue , Arnica pain relief gel (Walmart) all have relieved the symptoms associated with PN.
Have the best day possible!

April 22
A MyPrurigoTeam Member

Deb.....too funny evil Democrat & please know I definitely do not hold that against you, as to each their own! IMO, you are a good person suffering like all of us on this wonderful website! I do admit my political rant was totally out of line with the main issue at hand here which is to help peeps no matter what their choice of politics and/or religion are. Still learning at my old age to avoid talking politics and religion as the PN and LSC has evidently affected my 1/16th of a brain cell I hopefully have left (hmm good excuse, nada, LOL)! Also, I hope your scalp has calmed down more since Marilyn & us made a bad choice of products thinking we have a normal scalp, ugh! I am still quite inflamed which basically is just the norm for me, MEH! With May coming up soon, "May the Force be with Us All"! 🙏

April 26
A MyPrurigoTeam Member

Awe Christine8 thx for your support and caring! I know you have some major health problems, & my ❤️ goes out to you! Makes me feel good that I have you right by my side during these rust and lead years!! Deb seriously has renewed my hope w/all her knowledge & research she has provided to us! So true about the bandaid drugs as when we think we are going to possibly get some relief, and we don't! Thx for your inspiration as I too am gonna try to take a deep breath, & already trying to chill w/my improvised ice pack on my noggin'! Have a good night's rest and sleep! The Pink Full Moon tonight will hopefully bless us w/some mental and physical healing!🙏

April 23
A MyPrurigoTeam Member

I hope I am totally wrong and it will be on the market tomorrow, but It is my understanding that the clinical trials have to be completed before the drug can be approved. I just asked a friend who works for that branch of government, if that is true and she said yes. I can only see where they accepted the application and will give it priority reviews but it is not yet approved. “FDA physicians and scientists then review the drug research and the labeling information on how to use the drug. If the findings show the drug’s benefits outweigh its known risks — and that the drug can be manufactured in a way that ensures a quality product — the drug is approved and can be marketed in the U.S. The FDA will continue to monitor the drug post-approval.” (NIH.gov)
I think this is where Nemolizumab is right now. This may be why there is no date given as to when we can expect the drug to be available.

A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
Actual Study Start Date : January 11, 2021

Estimated Primary Completion Date : October 26, 2026

Estimated Study Completion Date : October 26, 2026

Oct 26, 2026 could include the post trial studies which can be submitted after approval.

“For the purposes of clinical trials, regulatory approvals include any approvals by government or health authorities regarding any research that includes human subjects. Additional approvals will be necessary if the research involves the use of an FDA regulated product.”

“The U.S. Food and Drug Administration (FDA) has accepted Galderma's Biologics License Applications for nemolizumab for the treatment of patients with prurigo nodularis and for adolescents and adults with moderate to severe atopic dermatitis. Nemolizumab was granted U.S. FDA Priority Review for prurigo nodularis.Feb 14, 2024”.

April 22 (edited)

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