Dive Brief:

• The Food and Drug Administration on Friday cleared a new use for Novo Nordisk’s Wegovy, granting accelerated approval of the popular weight loss drug in a common liver condition known as metabolic dysfunction-associated steatohepatitis, or MASH.
• Novo said the FDA OK’d use of Wegovy, alongside diet and exercise, in adults with non-cirrhotic MASH and “moderate-to-advanced” scarring of the liver. The conditional clearance is based on Phase 3 results showing Wegovy helped improve liver scarring without the condition worsening and resolve MASH without scarring getting worse.
• Wegovy became available in the U.S. for MASH Friday, making it the first GLP-1 agonist cleared for a condition Novo estimates affects around 22 million people in the U.S. The only other therapy specifically approved for MASH, Madrigal Pharmaceuticals’ Rezdiffra, has gotten off to a stronger-than-expected sales start.

Dive Insight:

Wall Street investors had some doubts of the sales potential of MASH drugs before approval of Rezdiffra last March. The disease, which is characterized by accumulation of liver fat, can go undiagnosed for years and is most definitively confirmed by an invasive liver biopsy. Some of its symptoms can be addressed by diet and exercise, too.

Rezdiffra has consistently topped investor benchmarks since launching, however. The drug generated $180 million in net sales in 2024 and $350 million over the first half of 2025, sending shares of its developer Madrigal to record highs. Analysts have revised their projections and some expect the drug to top $1 billion in annual sales as soon as next year.

Yet Madrigal will now have to contend with Wegovy, which is already a multibillion-dollar seller for its use treating obesity. Analysts have speculated that GLP-1 drugs like Wegovy, which have powerful effects on weight loss, heart health and other conditions, might upend the market for MASH drugs. Madrigal shares slumped following Wegovy’s approval Friday, reflecting concern about how the drug’s arrival might affect demand for Rezdiffra.

In a note to clients on Saturday, Leerink Partners analyst Thomas Smith, who covers Madrigal, predicted that some doctors and patients will choose Wegovy to treat MASH associated with an underlying metabolic condition.

However, there are “sizable sub-segments” of patients who won’t. Many MASH patients are already on GLP-1 drugs or are “lean,” Smith noted. There’s also an “increasing preference among clinicians and patients” for Lilly’s Zepbound for obesity and Mounjaro for diabetes, making it less likely people would switch to Wegovy because of the updated label.

Rezdiffra uptake there “will remain robust,” Smith speculated. Still, investors are wondering whether insurers might require some patients to take Wegovy first, or whether broad treatment guidelines might change given its availability, he noted.

Overall, though, Wegovy’s clearance, along with a drug label “mirroring” its clinical data, suggests the FDA’s comfort in granting accelerated approval to MASH drugs, Smith wrote. That could benefit other companies with MASH drugs in advanced testing, such as Akero Therapeutics, 89bio, and Sagimet Biosciences.