The FDA is finally going to act on the first drug for treatment of NASH
The FDA staff does not support approval - you can watch the meeting live if you care
A little background. The Intercept drug obeticholic acid or OCA is the first drug to meet the FDA requirement of reducing NASH fibrosis by at least one stage. There is no therapy for NASH and it is a serious unmet need. We all know that and the meeting tomorrow will end with a vote of whether to recommend approval.
It is a public meeting and I invite you to watch. If you have NASH this could be significant for you. They have a brief window for public comment and I get 4 minutes to speak on our behalf as patients.
There will be controversy about this vote whether they recommend or deny approval. The FDA released their internal staff analysis of OCA and the conclusion we draw from their presentation is that they don't support approval of this drug.
We believe this is a serious error and if the voting panel goes along with them it will be a major setback for patients and the field of drug development for NAFLD/NASH drugs.
The agency concern is that OCA can raise the LDL of patients and that it causes some to have itching.
In their analysis they ignore the fact that the LDL can be controlled with statins and if for some patients it can't, they can stop. There are also treatments for itching. They don't always work so again one could stop.
Our view, since this is the first and only drug before us that has met the FDA target for fibrosis reduction it should be approved for this serious unmet need.
As a patient, I'd be willing to take a statin along with OCA to manage my LDL, and for itch, I'd rather itch than die.
So many of you haven't taken our 2023 survey, The State of NAFLD/NASH Care in America. Most of you have ignored it. It is meetings like this FDA event where the weight of patient voices matter.
I do understand. I get many surveys that I just delete. Who has time? But if NAFLD/NASH affects you, you need to stand with us. I can huff and puff but without the support of the patient community I'm just a sad old guy making a fool of himself in the parking lot. Nobody cares until we band together so add your voice.
Do your part and take 20 minutes to help us along.