With fresh backing from the FDA, Novo Nordisk’s Wegovy has secured its third indication, becoming the second treatment approved for a severe type of fatty liver issue.
The FDA granted accelerated approval for Wegovy 2.4 mg in adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to severe fibrosis, or liver scarring, who do not already suffer from cirrhosis. The authorization applies to Wegovy used alongside a calorie-restricted diet and heightened physical activity, as per the release from the company.
The FDA’s conditional approval was given based on improvements in MASH and liver fibrosis among patients treated with Wegovy during the initial phase of a two-stage clinical trial, Novo stated. The second phase of the study, known as Essence, is still underway and anticipated to deliver results around 2029, according to earlier updates from the company.
MASH, previously referred to as nonalcoholic steatohepatitis (NASH), develops when excess fat accumulates in the liver and triggers long-term inflammation, which can eventually cause liver damage.
Novo estimates that about 5% of Americans have MASH, while globally, the condition affects roughly one in three obese or overweight individuals. Because it is difficult to detect in its early stages, the disease can advance if untreated, potentially leading to liver cancer, cirrhosis or even the need for a liver transplant, the company noted.
In the Essence trial, which tested once-weekly Wegovy in individuals with stage F2 or F3 liver fibrosis, 63% awitnessed the resolving of steatohepatitis without progression of fibrosis after 72 weeks, compared with 34% in the placebo group.
For the trial’s second primary endpoint, nearly 40% of patients on Wegovy showed betterment in liver fibrosis without worsening steatohepatitis, compared to less than less than a quarter for those in the control group.
On a separate confirmatory secondary measure, a third of Wegovy patients achieved both steatohepatitis resolution and fibrosis improvement by week 72, while only 16% of the placebo group reached that outcome.
Numerous pharmaceutical companies have attempted to create therapies for MASH, but most of those projects have ended in prominent failures. Novo itself faced a setback in 2022 when semaglutide produced underwhelming results in this disease. The FDA’s recent approval now validates Novo’s persistence in advancing the drug for MASH.
Beyond this new use, Wegovy already holds approvals for obesity and cardiovascular risk decrease, while its counterpart Ozempic is authorized for Type 2 diabetes. Together, Ozempic and Wegovy sparked the worldwide GLP-1 weight-loss boom, though in the key U.S. obesity market, Novo has gradually lost ground to Eli Lilly.
In other news, Madrigal Pharmaceuticals achieved a milestone in March when the FDA cleared its therapy Rezdiffra (resmetirom), marking the first official MASH treatment in the U.S. While Novo’s Wegovy and Madrigal’s Rezdiffra are both authorized for similar patient groups, their approaches differ significantly. Rezdiffra works as a thyroid receptor-beta agonist, acting directly on the liver, whereas Wegovy uses a distinct pathway.
