The FDA granted accelerated approval to resmetirom (Rezdiffra) as the first treatment for adults with noncirrhotic non-alcoholic steatohepatitis (NASH), also now referred to as metabolic dysfunction-associated steatohepatitis (MASH).
A once-daily oral agent, resmetirom is a liver-directed thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH; the drug is specifically indicated for NASH patients with moderate to advanced liver fibrosis, consistent with stages F2 to F3 fibrosis, and should be used along with diet and exercise, according to the agency.
“Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage,” said Nikolay Nikolov, MD, of FDA’s Center for Drug Evaluation and Research, in a statement. “Today’s approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise.”
A result of non-alcoholic fatty liver disease (NAFLD) progression, NASH can lead to liver fibrosis and dysfunction, raising the risk of transplant and hepatocellular carcinoma. The condition is often associated with hypertension and diabetes.
According to some estimates, 6 million or more Americans have NASH with stages F2 to F3 fibrosis, a number only expected to increase in the coming years.
Findings from the ongoing phase III MAESTRO-NASH study supported the approval, which reported NASH resolution with no worsening of fibrosis in 25.9% of patients on an 80-mg dose of resmetirom and 29.9% of those receiving a 100-mg dose, as compared with 9.7% of those given placebo (P
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