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.
Becker’s 3rd Annual Fall Chief Pharmacy Officer Summit is the top tier event that the people leading the future of pharmacy convene. This 3-day event is built specifically for Chief Pharmacy Officers and senior pharmacy leaders. The sessions examine the workforce, financial and clinical priorities shaping pharmacy today. Becker’s is where candid discussions flourish and new ideas thrive. Becker's 3rd Annual Fall Chief Pharmacy Officer Summit
