Novo Nordisk's obesity drug Wegovy (semaglutide 2.4 mg) has received accelerated FDA approval to treat metabolic dysfunction-associated steatohepatitis (MASH), a severe liver condition linked to obesity, based on positive results from the Phase 3 ESSENCE trial.

This marks the first time a GLP-1 receptor agonist is approved for treating MASH in adults, expanding Wegovy's therapeutic use beyond weight management and obesity.

The FDA approval covers adults with MASH who have moderate to advanced fibrosis, excluding cirrhosis, with most patients in trials maintaining the target dose until Week 72.

MASH is a serious liver disease characterized by fat buildup, inflammation, and scarring, often diagnosed late due to nonspecific symptoms, and can progress to cirrhosis, liver cancer, or require a transplant.

Approximately 1 in 20 people in the US have MASH, with about one-third of overweight or obese individuals affected, and the disease can be asymptomatic initially but lead to severe liver complications if untreated.

In clinical trials, 63% of patients treated with Wegovy achieved resolution of steatohepatitis without worsening fibrosis, significantly higher than the 34% on placebo.

The approval is supported by ongoing studies aimed at confirming the long-term clinical benefits of Wegovy for MASH.

This milestone highlights Wegovy as the first GLP-1 receptor agonist approved for MASH, with further studies underway to verify its long-term efficacy.

Wegovy is also indicated for weight management and reducing cardiovascular risk in adults with obesity or overweight, with previous approvals in the US, EU, and Japan.

Most patients in trials (83.5%) maintained the target dose until Week 72, demonstrating good adherence and tolerability.

The drug's safety profile includes potential risks such as thyroid tumors, pancreatitis, gallbladder issues, hypoglycemia, dehydration, allergic reactions, and cardiovascular effects, necessitating careful monitoring.