The FDA has approved Novo Nordisk’s Wegovy to treat metabolic associated steatohepatitis, or MASH, in adults who have excessive scar tissue in the liver.
MASH is a serious liver condition linked to obesity, Type 2 diabetes and high cholesterol, affecting approximately 14.9 million adults in the U.S., according to an Aug. 15 news release from the agency.
The approval is based on interim results from an ongoing phase 3 clinical trial, in which 63% of participants receiving Wegovy had MASH resolution with no worsening of liver scarring, compared to 34% receiving a placebo. In addition, 37% of patients on Wegovy showed improvement in liver scarring compared to 22% on the placebo.
The FDA granted the approval under its accelerated pathway, which allows earlier access to drugs for serious conditions based on evidence, the release said.
