Novo Nordisk hit an important milestone on 1 November as it reported successful Phase III data for semaglutide in non-alcoholic steatohepatitis (NASH), marking the first time a GLP-1 receptor agonist demonstrated statistical significance for fibrosis reduction and/or NASH resolution. Analysts saw the results as largely comparable to the benefit seen with the first drug approval for NASH, Madrigal’s Rezdiffra.
Key Takeaways
- Novo Nordisk reported top-line Phase III data showing that its GLP-1 agonist semaglutide can reduce fibrosis and clear NASH.
- The Denmark-based pharma intends to seek US and EU approval for semaglutide – already approved for type 2 diabetes as Ozempic and obesity and Wegovy – in NASH during 2025
The data came from the 1,200-patient Phase III ESSENCE study, which is intended to back initial approval and in the longer-term provide hepatic benefit outcomes data for semaglutide 2.4mg given weekly, the same dosing regimen used for the drug in obesity under brand name Wegovy
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