On Friday, the FDA granted accelerated approval to Novo Nordisk’s Wegovy for the treatment of metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced fibrosis but without cirrhosis.

The once-weekly 2.4 mg semaglutide subcutaneous injection is given in conjunction with a reduced calorie diet and increased physical activity.

Among people living with overweight or obesity globally, 1 in 3 also have MASH.

The accelerated approval was based on part-one results from the ongoing two-part, phase-3 ESSENCE trial , in which Wegovy demonstrated a significant improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis, compared with placebo at week 72. Those results were published onl

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