Madrigal drug Resmetirom approved by FDA - Living with Fatty...
Madrigal drug Resmetirom approved by FDA
Yay....what great great news!!!! Thank you you two, for all your work.
Hopefully the start of many drugs yet to come that will help so many folks in need of assistance for this dreadful disease! So many things yet to be worked out but a great big thanks to Madrigal for all the hard work they put in. Many thanks to patient advocates such as Wayne and Rosemary for all their selfless help !
Thanks Wayne - So happy for this day! Now I’m hoping that Madrigal Pharmaceuticals might help those of us who participated in the Resmetirom clinical trials to afford to go back on the drug
Char
Thank you Wayne and everyone involved for all these years for all the hard work!
Can cirrhosis patients benefit from this new drug?
At this point it is not approved for F4 NASH patients. That group is being studied but for now approval is limited to F2 and F3.
what about my MRE score is 4.2kpa (F3-F4) ??can i maybe qaulify?
You may be a candidate. It depends on what your doc thinks the condition of your liver is. That range may qualify if there are no contraindications but your doc has to go to bat for you by signing off on the treatment plan.
Got it, Thanks so much for tour feedback
Also just curious have you ever got a biopsy done?
I've had 3
I will have one done for the 1st time as my test for the exception of Fibro & MRE show elevated liver stiffness but my Hepatologist thinks that b/c I have a large surgery from past on my stomach near the Liver & my gallbladder incision as well the imaging my be picking that up as well
Wonderful news! Do you know if you have hypothyroidism and take Synthroid can you still take this new drug since it affects the thyroid metabolism?
I don't think it is contraindicated but would require careful monitoring by your doc
Hi Kathiy- I participated in the Madrigal clinical trials for this drug and for the 2nd year I was definitely on the drug. I took 80mg for the 1st 2 months & 100mg for the remaining 10 months of the year. I am hypothyroid and take Synthroid which Madrigal was aware of. I had no probems and in fact during that year my Synthroid had to be reduced for the 1st time in a long time to the lowest dose I’ve ever been on. So it seemed to improve my thyroid function. Since I’ve now been off the trial drug for 16 months, my Synthroid dose had to be increased again back to the dose I was on before taking the trial drug. Also, I don’t know if other participants had this experience, but my statin dose had to be reduced to 5mg. I’ve never been on a dose less than 10mg until then. And my cholesterol is still controlled with the 5mg dose. So in my case this drug seemed to not only benefit my liver, but also my thyroid and cholesterol.
Thank you for your information. That is wonderful it worked so well for you! I am on a 10mg statin Crestor also. I am hoping this drug is not crazy expensive on Medicare part D. I see my hepatologist in few weeks so I plan on discussing. If you don't mind sharing how much did it benefit your liver?
On October 15, 2021 when I was ready to begin the trial year on the drug my kPa was 11.9. (An improvement of my 2018 score of 14.0). At the end of the trial after 12 months on Resmetirom my kPa was 6.4, so I dropped from 11.9 kPa to 6.4 kPa during the year on the drug.
I had worked at eating healthier and losing weight and had reduced my CAP on my own from 400 to 233, but the kPa was slower to improve. My CAP was 236 at end of trial so hadn’t changed much during the year. But the improvement in kPa was amazing.
Did you also lose weight because it helped your thyroid?
I have a question Wayne. First, this is great news. Now I heard you on a podcast discussing this drug and you said it wouldn't be available for you because you're F4.
However, you've said you regressed to an F2/F3, so why wouldn't it be available for you or people with your disease state?
At some point I'll explore that. Given that I have had biopsy verified bridging fibrosis at diagnosis the question is what really happened over time with my drop in stiffness. The study didn't analyze patients like me so it is unclear whether it will be effective for a recovering patient rather than one in the primary course of developing disease. That data will be developed over time and since I'm doing well there isn't a great argument to seek an expensive drug right now. In my case I am more likely to eventually take one of the fibrosis specific drugs currently in phase 3 trials.
What drugs are in phase 3 for fibrosis?
The NASH pipeline includes several late-stage candidates that act through a diverse set of mechanisms (Table 1).
Table 1 | Selected drugs in development for NASH
Drug Company Properties Status
Resmetirom Madrigal THRβ agonist Approved
VK2809 Viking THRβ agonist Phase II
Efruxifermin Akero FGF21 analogue Phase III
Pegozafermin 89bio/Teva FGF21 analogue Phase III
Lanifibranor Inventiva Pan-PPAR activator Phase III
AZD-2693 AstraZeneca PNPLA3 ASO Phase II
Rapirosiran Regeneron/Alnylam HSD17B13 siRNA Phase II
ION224 Ionis DGAT2 ASO Phase II
Incretin mimetics
Semaglutide Novo Nordisk GLP1 agonist Phase III
Tirzepatide Lilly GLP1/GIP co-agonist Phase II
Survodutide Boehringer Ingelheim/Zealand Pharma GLP1/glucagon co-agonist Phase II
