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First NASH drug to report a successful phase 3 trial

It is very early and we don't know a lot yet but Intercept Pharmaceuticals has just released results of their Phase 3 test of Obeticholic Acid as a possible treatment for NASH.


This is a major step for us as patients.  We all know the story.  The doc says sadly, "You have cirrhosis, I'm sorry we have no treatment".  This is a refrain we see retold thousands of times here at the Foundation and it is the path I have personally traveled. I've written that we are on the brink of a new day when we will have options.  This is the dawning of that day.

To be clear, there are miles to go before an effective therapy is available and this doesn't even prove that this will be it.  It does give us confidence that we are getting close.

My advice.  Don't die and if you want to give up, just say no.  The hopelessness that can be such a part of this disease need not be part of your life now.  We don't know exactly how or when but we do know it will be possible to get help for this disease.

In the meantime, go here and eat your vegetables.

Based on these results, Intercept intends to file for approval in the U.S. and Europe in the second half of 2019. OCA remains the only investigational drug to have received Breakthrough Therapy designation from the FDA for NASH with fibrosis. REGENERATE results will be presented at the European Association for the Study of the Liver (EASL): The International Liver CongressTM 2019.