INTERCEPT RESUBMITS NEW DRUG APPLICATION TO FDA FOR OBETICHOLIC ACID IN PATIENTS WITH LIVER FIBROSIS DUE TO NASH

A SURPRISE CHRISTMAS PRESENT FOR PATIENTS WITH FIBROSIS. IF YOU WOULD LIKE TO READ THE PRESS RELEASE CLICK HERE.

A bit of history may be helpful to many. Obeticholic Acid (OCA) was filed with FDA in 2019 but FDA didn't go through with a planned patient meeting called an adcom and instead issued what they called a complete response letter in June of 2020 and raised questions about safety.  They did not reject the application they just punted.  The department was going through some reorganization at the time and from a patient perspective we did not believe the sequence was proper but we were stuck with it.  Most companies would have abandoned the effort at that point.  To their great credit Intercept believed in the drug and continued their studies to answer the safety questions that had been raised.  Now they have much more data and good evidence of safety which we believe should resolve that issue.

An important point that many don't realize is that OCA is already being used to treat liver disease. It is approved for PBC (primary biliary cholengitis) which is a disease of the bile distribution network of the liver which leads to fibrosis. Because of the success with that specific condition it was studied for the larger problem of NASH.  It is important to know that OCA was the first drug to meet an endpoint that FDA had set for NASH drugs. It was this combination of facts that led us as patients to believe in 2020 that we would have the first therapy for NASH.

A brief tour of chemistry but stick with me, it will be easy. The liver has many potential pathways for treatment because it does so many things but a key process is how bile acids are managed and a key chemical pathway is known as FXR. Bile is a key product of the liver made primarily from cholesterol which is sent into the intestines and is critical to the digestion of fats. The proper processing of fats or lipids is crucial to health and a well functioning FXR system is key to that so a lot of companies are trying to find ways to work there. Toxic byproducts of lipid metabolism are one of the things that contribute to the formation of fibrosis. OCA is the first to demonstrate positive results meeting FDA guidelines and an interesting fact from the studies is that it appears to work somewhat better on more advanced cases. More analysis is no doubt needed but this is very encouraging.

This starts a 6 month clock, (seemingly everything at FDA starts with 6 months) so we will keep you informed but this is good news and is earlier than we had expected so Merry Christmas from Intercept.

As a reminder as we would like you to be sure to check this out, we gave a demo of The Wellness League which will be the main patient outreach platform for us in the future. It is a short, 30 minute, description of our strategy for delivering patient support.  Click the link below to watch it.

CLICK TO VIEW THE WELLNESS LEAGUE DEMO

Patient care and therapies are changing fast and keeping you informed is an important part of our job.