Danish big pharma Novo Nordisk has been given the go-ahead for its star weight loss drug, Wegovy (semaglutide), in patients with metabolic dysfunction-associated steatohepatitis (MASH) who have moderate-to-advanced liver scarring.
This makes it the first glucagon-like peptide 1 receptor agonist (GLP-1RA) to be approved by the US Food and Drug Administration (FDA) for this indication.
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Wegovy obtained accelerated approval in MASH based on the outcome of the Phase III ESSENCE trial (NCT04822181), which found that a weekly dose of subcutaneous Wegovy could resolve steatohepatitis – a severe form of fatty liver disease – in 63% of patients. This was compared to 34% in the placebo group.
Wegovy also helped to improve liver fibrosis in 37% of patients compared with 22% in the placebo group.
The drug’s full approval is conditional on the results of the ongoing ESSENCE study, which will continue to assess the long-term benefits of Wegovy alongside a reduced-calorie diet and increased physical exercise.
Novo Nordisk’s best-selling weight loss drug now joins Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) on the market, which was the first medication to be approved in noncirrhotic MASH in March 2024.
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By GlobalDataAccording to analysts at Pharmaceutical Technology’s parent company, GlobalData, Rezdiffra is expected to reach blockbuster status by 2026, raking in $1.1bn for Madrigal after two years on the market. By 2031, the drug is forecast to pull in $4.8bn for Madrigal – highlighting its rapid growth trajectory moving forward.
It will be interesting to see how Wegovy competes with Rezdiffra in this indication, as the thyroid hormone receptor beta (THR-β) agonist’s fibrosis improvements were similar to those seen with Wegovy. However, it does have the benefit of oral administration, which is more convenient for patients.
GlobalData pharma analyst Jay Patel said: “This outcome makes Wegovy the second US-approved asset in MASH, applying competitive pressure to Madrigal’s Rezdiffra.
“Nevertheless, Rezdiffra’s liver-directed effect may have advantages in treating advanced fibrosis, and Madrigal may choose to emphasise this in future marketing, although fibrosis improvement results from the Phase III MAESTRO-NASH trial of Rezdiffra were broadly similar to ESSENCE.”
However, the drug’s approval will still be welcome news for Novo Nordisk, which is currently in a head-to-head battle with Eli Lilly for GLP-1RA glory.
The two companies are currently fighting for market share in the type 2 diabetes (T2D) and weight loss markets, with sales of Nordisk’s Ozempic and Wegovy slowing due to competition from Lilly’s Zepbound and Mounjaro (tirzepatide), which brought in $8.57bn in Q2.
However, Lilly’s oral GLP-1RA candidate, orforglipron, failed to surpass the efficacy of Nordisk’s oral semaglutide in a Phase III trial in weight loss, causing the former’s shares to drop by 12% to $656.19 after market open post-data release.
Though Novo Nordisk attained approval in MASH first, Lilly is also investigating Zepbound in this indication, with a Phase IIb trial having shown signs of efficacy.
