The Food and Drug Administration has approved a weight loss drug called Wegovy for a liver disease, the agency announced on Aug. 18.
Wegovy is now approved for treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that impacts approximately 6 percent of American adults, the FDA said in a statement.
Updated labeling for Wegovy now lists the treatment.
“The indication for MASH is approved under accelerated approval based on improvement of MASH and fibrosis,” it states. “Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial.”
Data supporting the approval came from an interim analysis, at week 72, from a phase 3 double-blind, placebo-controlled trial that’s designed to last for 240 weeks. Patients who received Wegovy were more likely to experience improvement in liver scarring, with no worsening of liver disease….