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Investing.com -- Novo Nordisk (CSE:NOVOb) said on Friday that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for its weight-loss drug Wegovy to treat metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease.
The move further expands the company’s reach in the metabolic disorders market.
Shares in Novo Nordisk opened roughly 4% higher on Monday.
Wegovy becomes the first GLP-1 based therapy authorized for MASH, which affects roughly 5% of U.S. adults, according to the American Liver Foundation. Until now, the only FDA-approved treatment for the condition was Madrigal Pharmaceuticals’ Rezdiffra, cleared in 2024.
The FDA approval is backed by the phase 3 ESSENCE trial, which tested once-weekly Wegovy 2.4 mg in adults with MASH and moderate to advanced liver fibrosis, showing results at Week 72.
"Today’s decision by the FDA reflects the continued progress in how we understand and treat patients with MASH, bringing us closer to care that meets the needs of people living with this disease," said Arun Sanyal, MD, Director at Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University.
"If left untreated, MASH can lead to serious and potentially fatal outcomes. The clinical evidence seen in ESSENCE underscores the promise of this approach to treating adults with MASH with moderate to advanced liver fibrosis."
The approval is supported by the first phase of a two-part trial, which showed Wegovy improved liver health and reduced scarring in more patients compared with a placebo. The drug is now available in the U.S. for adults with MASH and moderate to advanced liver scarring, to be prescribed alongside diet and exercise.
"The FDA’s conditional approval of Wegovy for the treatment of adults with noncirrhotic MASH marks a truly pivotal milestone and a significant step forward for the MASH community and those seeking new options," Dave Moore, executive vice president of U.S. Operations at Novo Nordisk, said.
Novo Nordisk has also filed for approval in Europe and Japan based on the early trial results, with data from the second phase of the study expected in 2029.
Accelerated approvals allow the FDA to expedite treatments for serious conditions, though critics note some drugs later fail to demonstrate lasting benefits.