Novo Nordisk (NOVOb.CO), opens new tab said on Friday the U.S. Food and Drug Administration has granted accelerated approval for its weight-loss drug Wegovy to treat a serious liver condition called metabolic dysfunction-associated steatohepatitis, strengthening its presence in the metabolic disease market.
The approval makes Wegovy the first GLP-1 class therapy cleared for MASH, a progressive liver condition that affects around 5% of adults in the United States, according to the American Liver Foundation.
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“There really (have) not been good treatments in this space. We’re only the second FDA-approved treatment for MASH, and we really need better medications that have better overall benefit-risk profiles, that really can also prevent the progression of the disease,” Jason Brett, principal U.S. medical head at Novo Nordisk, said in an interview with Reuters.
So far, the only available FDA-approved treatment for MASH is the Madrigal Pharmaceuticals drug (MDGL.O), opens new tab Rezdiffra, which was approved in 2024.
The FDA’s decision was based on part one of an ongoing two-part study that showed Wegovy helped improve the organ’s condition in more patients with MASH and liver scarring, compared to a placebo.
Novo Nordisk said the drug is now available in the United States for adults with MASH and moderate to advanced liver scarring, and is to be used alongside proper diet and exercise.
“MASH patients need access to treatments – and that really can help them, especially early – to prevent it from progressing,” Brett said. “We’re doing as much as we can to work and partner with the payer community around enhancing access and reimbursement.”
Brett did not provide any pricing details.
Based on results from part one of the trial, Novo has applied this year for approval in Europe and Japan. Further results from part two of the trial are expected in 2029.
Rival Eli Lilly’s (LLY.N), opens new tab tirzepatide – the active ingredient in its popular diabetes drug Mounjaro and weight-loss treatment Zepbound – previously helped up to 74% of patients achieve absence of MASH with no worsening of scarring in a mid-stage trial.
Accelerated approvals allow the FDA to move therapies that target serious and life-threatening conditions to the market more quickly. However, such approvals have been criticized because some drugs have later been proven to be ineffective.
