The US FDA has granted accelerated approval to Novo Nordisk’s semaglutide (Wegovy) 2.4 mg injection for adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis, excluding cirrhosis. The decision is based on part 1 of the phase 3 ESSENCE trial, where semaglutide significantly improved liver histology at 72 weeks. In the study, 63% of patients achieved resolution of steatohepatitis with no worsening of fibrosis compared with 34% on placebo.
“Wegovy is now uniquely positioned as the first and only GLP-1 treatment approved for MASH, complementing the already proven weight loss and cardiovascular benefits linked to semaglutide,” said Martin Holst Lange, Chief Scientific Officer at Novo Nordisk. Arun Sanyal, MD, of Virginia Commonwealth University, added, “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.”
With MASH affecting an estimated 22 million people in the US, this approval provides a long-awaited treatment option and expands Wegovy’s established indications in obesity, pediatric obesity, and cardiovascular risk reduction. Medical professionals are excited about the news, noting that it provides a long-awaited treatment option that could help many people.
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