Novo Nordisk’s Wegovy receives FDA approval to treat MASH liver disease

USA—Novo Nordisk has received approval from the U.S. Food and Drug Administration (FDA) for its leading weight loss drug, Wegovy (semaglutide), to treat patients with metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver scarring.

This marks the first time a glucagon-like peptide 1 receptor agonist (GLP-1RA) has been approved for this condition in the United States.

The FDA granted accelerated approval for Wegovy based on positive results from the Phase III ESSENCE trial, which evaluated its effectiveness in patients with MASH.

 In the trial, a weekly injection of Wegovy resolved steatohepatitis, a serious form of fatty liver disease, in 63% of patients, compared to 34% who received a placebo.

In addition to resolving steatohepatitis, Wegovy improved liver fibrosis, the thickening and scarring of liver tissue, in 37% of patients, versus 22% in the placebo group.

Full approval for Wegovy depends on continued assessment of its long-term benefits in the ongoing ESSENCE study.

This trial also investigates how the drug works in combination with lifestyle changes such as a reduced-calorie diet and increased physical activity.

Wegovy’s approval adds a significant new option alongside Madrigal Pharmaceuticals’ Rezdiffra (resmetirom), which was the first drug approved for noncirrhotic MASH in March 2024.

According to analysts at GlobalData, a pharmaceutical research firm, Rezdiffra is expected to become a blockbuster drug by 2026, generating approximately US$1.1 billion in annual sales within two years of its launch.

 Sales could reach US$4.8 billion by 2031, reflecting strong growth projections.

It will be interesting to observe how Wegovy competes with Rezdiffra, especially since both drugs demonstrated similar improvements in liver fibrosis.

However, Rezdiffra offers the convenience of oral administration, which could be more appealing to patients compared to Wegovy’s injectable form.

GlobalData’s pharma analyst Jay Patel noted that Wegovy’s approval as the second FDA-approved treatment for MASH will increase competition for Madrigal’s Rezdiffra.

He also mentioned that Rezdiffra’s direct liver-targeted effects might provide an advantage in treating advanced fibrosis, even though fibrosis improvement results from its Phase III MAESTRO-NASH trial were comparable to the ESSENCE trial outcomes for Wegovy.

Novo Nordisk’s approval is timely, as the company faces stiff competition from U.S.-based Eli Lilly in both the type 2 diabetes and weight loss markets.

Sales of Novo Nordisk’s Ozempic and Wegovy have slowed due to competition from Lilly’s drugs Zepbound and Mounjaro (tirzepatide), which earned US$8.57 billion in the second quarter alone.

Nevertheless, Lilly recently experienced a setback when its oral GLP-1RA candidate, orforglipron, failed to demonstrate superior weight loss efficacy compared to Novo Nordisk’s oral semaglutide in a Phase III trial.

Following this news, Lilly’s stock dropped by 12%, falling to $656.19 per share shortly after market open.

Despite Novo Nordisk’s early lead in obtaining FDA approval for MASH, Lilly is actively pursuing this indication as well.

Their drug Zepbound is currently undergoing a Phase IIb trial, which has shown promising signs of efficacy in treating MASH.