Currently there is no U.S. Food and Drug Administration-approved medicine for nonalcoholic steatohepatitis, also referred to as NASH.

NASH is a fatty liver disease that can lead to liver failure, writes John George for Philadelphia Business Journal.

People with this condition have an inflamed liver that can lead to scar tissue on the liver. NASH is mostly a silent disease. Patients often don’t know they have it until it is severe, and they need a liver transplant.

A Montgomery County pharmaceutical company, however, is hoping to finally offer NASH patients some hope with its experiential treatment.

Madrigal Pharmaceuticals in West Conshohocken is ready to submit its drug resmetirom to the FDA for approval. It is a rolling admission, with a potential decision expected by the beginning of 2024.

Other companies have attempted to get FDA approval for their NASH treatments including Intercept Pharmaceuticals, AstraZeneca, Novartis, Pfizer, Bristol Myers Squibb, and Gilead Sciences. But so far no NASH drug has received an official nod yet.

The FDA granted resmetirom Breakthrough Therapy designation in April for treatment of patients with NASH with fibrosis. This allows Madrigal to submit its new drug application in sections as they are completed instead of waiting until the entire application is finished.

Read more about the new NASH treatment in the Philadelphia Business Journal.

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Understanding NASH.