According to the National Institutes of Health (NIH), nonalcoholic steatohepatitis (NASH) is a form of nonalcoholic fatty liver disease (NAFLD). The NIH defines NAFLD as a condition in which a buildup of fat—not caused by heavy alcohol consumption—occurs in the liver. Patients with NASH also have inflammation of the liver, known has hepatitis, and resultant liver cell damage.
According to the American Liver Foundation (ALF), NASH currently affects between 6.5 million to 16.3 million Americans, and up to 25% of adults with NASH may also have liver cirrhosis. By 2030, ALF reports NASH is expected to be the most frequent reason for liver transplants in the United States.
Current management and NASH pipeline drugs
According to the American Association for the Study of Liver Diseases the management of patients with NASH consists of treating liver disease as well as the associated metabolic comorbidities such as obesity, hyperlipidemia, insulin resistance, and type 2 diabetes mellitus.
Related: Biosimilars in the Pipeline
There are currently no FDA-approved medications for the treatment of NASH, but the guidelines recommend lifestyle modifications like weight loss, pioglitazone (biopsy-proven NASH), and vitamin E as treatment options.
Empagliflozin (Jardiance) is showing promise for patients with type 2 diabetes and NAFLD based on positive results from the E-LIFT trial and Diabetologia study demonstrating the medication reduces liver fat. Intercept has submitted the new drug application for obeticholic acid (Ocaliva) for the treatment of liver fibrosis due to NASH and was granted priority review by the FDA, with a target approval date of March 26, 2020.
Obeticholic acid has a unique mechanism of action as an oral farnesoid X receptor (FXR) agonist. It’s the only therapy the FDA has designated as a Breakthrough Therapy for NASH with fibrosis, according to results from the phase 3 REGENERATE study.