US EditionSemaglutide Gets FDA Greenlight for MASH
Wegovy improved liver fibrosis in 37% of patients and resolved steatohepatitis in 63%, becoming the first FDA-approved GLP-1 receptor agonist for MASH treatment.
- This year, the U.S. Food and Drug Administration approved Wegovy for MASH, making it the first GLP-1RA approved for this indication.
- At the moment, the only FDA-approved therapy for steatohepatitis is Rezdiffra, which had around $350 million in sales last year, but this is not mentioned in the source context.
- In Part 1 of the ESSENCE trial involving approximately 800 patients, Wegovy showed 62.9% steatohepatitis resolution and 37% fibrosis improvement versus 22% on placebo.
- The approval could unlock a market potentially worth tens of billions for Wegovy and keeps Novo Nordisk's lead over Eli Lilly in the GLP-1 market race for MASH indications.
- While full approval depends on ongoing ESSENCE study results, GlobalData pharma analyst Jay Patel notes that Lilly’s Phase III trial for Zepbound, concluding in October 2026, will shape future competition.
29 Articles
29 Articles
FDA Approves Weight Loss Drug Wegovy for Liver Disease
The Food and Drug Administration approved a weight loss drug called Wegovy for a liver disease, the agency announced on Aug. 18. Wegovy is now approved for treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that impacts approximately 6 percent of American adults, the FDA said in a statement. Updated labeling for Wegovy now lists the treatment. “The indication for MASH is approved under acce…
MedPage Today
Anti-Aging, Acupuncture and Health NewsSemaglutide Gets FDA Greenlight for MASH
(MedPage Today) -- The FDA expanded the indication for semaglutide (Wegovy) to treating adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), the agency announced. The glucagon-like peptide-1 (GLP-1) receptor agonist...
FDA Approval Expands Novo Nordisk’s Wegovy to the Fatty Liver Disease MASH
Novo Nordisk’s GLP-1 drug Wegovy expanded its label to include the metabolic disorder known as MASH. Analysts say there’s room for many MASH drugs with the treatment landscape expected to shape up to include combinations of therapies bringing different approaches to this fatty liver disease. The post FDA Approval Expands Novo Nordisk’s Wegovy to the Fatty Liver Disease MASH appeared first on MedCity News.
Pharmalittle: We're reading about a setback for Pfizer, a boost for Novo Nordisk, and much more
Good morning everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of deadlines, online meetings, and phone calls has predictably returned. But what can you do? The world, such as it is, continues to spin. So time to give it a nudge in a better direction by brewing cups of stimulation. Our choice today is maple cinnamon French toast. Goes well with a hearty b…
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