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FDA advisory panel votes against NAFLD/NASH therapy

The FDA advisory panel voted to reject Intercept's application for OCA as a treatment for NASH

Despite meeting the goals set by FDA, of reducing fibrosis by at least one stage, the GIDAC panel today voted against approval of obeticholic acid as a treatment for NASH.

As a patient, I'm very concerned by this decision.  The concern expressed by the panel was that there was an increased risk of bile duct disease in a small number of patients in the clinical trial.  The exact statistics will be published but we believe that the number is small compared to the number of people who will die from the disease if untreated Personally, I'd like to be able to have a chance to decide that risk for myself.  I believe that most hepatologists know how to manage those risk factors.

For me, the most important thing about the drug was that by showing that for some people it could reduce fibrosis it proved that for a larger group it would be able to slow or stop progression.  For someone who has not yet become a cirrhosis patient that is the most important thing.  Don't make me get really sick before you pay attention to my problems. That argument had no support at all except from the single liver patient who they included on the panel. She spoke eloquently about the need that patients have but no one even acknowledged that her  point of view might have merit.

You have all watched the news and you know that the only groups who get anything done in this country stand together and insist that they be heard.  That is why I continue to plead with you to at least take our 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 needs to matter. I realize that when you are ill it is hard to be bothered but unless we somehow become a force with some weight we just remain really good income producers for the system.

If NAFLD/NASH affects you, you need to stand with us.  Nobody cares until we band together so add your voice.

Do your part and take 20 minutes to help us along.

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