New Treatment for Fatty Disease: FDA Rejects NASH Drug OCA

Individuals hoping for a new treatment for fatty liver disease may still need to wait longer. A few months ago, the US Food and Drug Administration (FDA) didn't approve the potential drug, obeticholic acid (OCA).

New Treatment For Fatty Liver Disease

Individuals with fatty liver were hoping for an approved treatment this year. However, they were left disappointed after the FDA decided against Intercept Pharmaceutical's second bid for the approval of obeticholic acid (OCA) for the treatment of nonalcoholic steatohepatitis (NASH) or nonalcoholic fatty liver disease (NAFLD) with stage 2 or 3 fibrosis.

The FDA made its decision based on suggestions during last month's FDA Gastrointestinal Drugs Advisory Committee meeting. Members recommended postponing approval until clinical outcome data become available by a vote of 15 to 1. The FDA meeting briefing document stated that "there is uncertainty how the magnitude of changes in these surrogate endpoints may translate to meaningful changes in clinical outcomes," even though OCA improved fibrosis in NASH patients with a moderate benefit over placebo, according to Intercept's clinical trial data. Notable safety issues also included a higher chance of drug-induced liver damage.

Intercept sought FDA approval for OCA to treat NASH in 2019 and received a complete response letter. The company refiled for a new drug application in December and got rejected for the second time.

There are no FDA-approved treatments for NASH, a disorder that affects 16.8 million Americans, according to estimates.

Intercept intends to quickly start wrapping up its NASH clinical trial and reorganizing to concentrate on uncommon and severe liver conditions.

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How to Manage Fatty Liver Disease

Individuals who are obese or have type 2 diabetes are more likely to develop nonalcoholic fatty liver disease. Approximately 75% of overweight individuals and 90% of severely obese individuals are affected.

Fatty liver disease can also be brought on by excessive alcohol use. Alcohol-associated fatty liver disease is the term for this.

Since fatty liver has no medication, the only thing one can do to manage the condition is to eat a healthy diet and exercise regularly. To reverse fatty liver disease, experts recommend three cups of coffee daily, four tablespoons of olive oil daily, and a Mediterranean diet.

The 1990s saw the rise in popularity of the Mediterranean diet, better understood as an eating style than a strict diet. Fruits, vegetables, whole grains, beans, nuts, legumes, olive oil, flavorful herbs, and spices are all encouraged. Fish and seafood should be consumed at least a few times a week, and poultry, eggs, cheese, and yogurt in moderation. Sweets and red meat should be saved for special occasions.

The Mediterranean diet is beneficial for those who have nonalcoholic fatty liver disease and has also been demonstrated to lower blood pressure, harmful LDL cholesterol, and heart disease risk. Additionally, it is in line with the American Diabetes Association.

Here is a summary of the tips to fight fatty liver: