The medication was fast-tracked through the agency’s accelerated approval pathway.
The U.S. Food and Drug Administration (FDA) has authorized Rezdiffra (resmetirom) for adults experiencing noncirrhotic non-alcoholic steatohepatitis (NASH), with moderate to advanced liver scarring (fibrosis), along with diet and exercise. The agency’s accelerated approval pathway recognized Rezdiffra as a Breakthrough Therapy, Fast Track, and Priority Review designated medication.
Rezdiffra is a partial activator of a thyroid hormone receptor and operates by curbing liver fat accumulation. The condition is a consequence of nonalcoholic fatty liver disease progression, in which prolonged liver inflammation can result in liver scarring and dysfunction, often linked with conditions such as high blood pressure and type 2 diabetes.
“Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage,” said Director Nikolay Nikolov of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise.”
As the Lord Leads, Pray with Us…
- For FDA researchers to be prudent as they provide feedback and review the results of studies and trials.
- For Commissioner Robert Califf to receive God’s wisdom as he heads the FDA.
Sources: Food and Drug Administration
