FDA Approves First-Ever Drug for Serious Liver Condition
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 […]
‘Game Changer’ in NASH: Resmetirom Hits Endpoints in Pivotal Study
VIENNA — The investigational agent resmetirom resolved liver biopsy findings in nonalcoholic steatohepatitis (NASH) more often than placebo, according to the phase III MAESTRO-NASH trial. While 10% of placebo patients achieved resolution of inflammation, ballooning, and disease activity, the rate was 26% among people treated with the 80-mg dose of resmetirom and 30% with the […]