Intercept has withdrawn its application for obeticholic acid (OCA) as a treatment for nonalcoholic steatohepatitis (NASH) in Europe. This decision comes after the FDA rejected the company’s application in the U.S. last year. While this withdrawal is not a surprise, it is a disappointment to NASH patients, who still live without an approved treatment option.

About NASH

First, let’s take a look at what NASH is. Nonalcoholic steatohepatitis affects those who drink very minimally or not at all, causing an accumulation of fat in the liver. This leads to inflammation and scarring which may go on to impact liver function. Currently, this condition affects up to 25% of Americans but still faces an unmet medical need. While research is being conducted to fill this gap, the treatment options that exist now are lowering cholesterol, losing weight, controlling diabetes, avoiding alcohol, and maintaining a healthy diet and exercise regimen.

Symptoms of NASH include:

• Jaundice
• Itching
• Weakness
• Nausea
• Vomiting
• Fatigue
• Swelling in the legs and abdomen
• Mental confusion
• Loss of appetite
• Abdominal pain
• Spider-like blood vessels

About the Application Withdrawal

Initially, Intercept submitted applications in the United States and Europe at the end of 2019. This was after the company reported positive results from their phase 3 REGENERATE trial, making it the first biotech company to do so. Unfortunately, the data sourced from this trial was not enough, and the FDA denied the application in 2020 while requesting more information.

After this request, Intercept began to gather more data, but the timing simply did not work out. It was not able to incorporate any new data in its application in Europe, leading the company to withdraw it completely.

This does not mean that OCA will never be available to NASH patients, however. Intercept is currently reanalyzing data from the REGENERATE trial, along with sourcing data from a new phase 3 trial titled REVERSE.

Hopefully, this data proves that OCA is a viable option for NASH and supports the resubmission of an application. If all goes well, Intercept could refile next year.

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