CHMP adopts a positive opinion for Kayshild (semaglutide) to treat metabolic dysfunction-associated steatohepatitis – Novo Nordisk

The EMA’s CHMP adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Kayshild (semaglutide), intended for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH). The applicant is Novo Nordisk A/S.

Kayshild will be available as a 0.25 mg, 0.5 mg, 1 mg, 1.7 mg and 2.4 mg solution for injection in pre-filled pens. The active substance of Kayshild is semaglutide, a glucagon-like peptide-1 (GLP-1) analogue (ATC code: A10BJ06). Semaglutide is a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor. The GLP-1 receptor is not expressed in the liver, and the liver-specific mechanism of action is mediated through improvement in metabolic factors, including weight loss, improved glucose and lipid metabolism, and reduced inflammation. Moreover, semaglutide reduces liver fat deposition.

The benefits of Kayshild are the resolution of MASH with no worsening of liver fibrosis as well as an improvement in fibrosis with no worsening of MASH compared with placebo, as observed in a multicentre, randomised, double-blind, placebo-controlled clinical trial in adults with MASH and moderate to advanced liver fibrosis (ESSENCE, NCT04822181). The most common side effects with Kayshild are gastrointestinal disorders, including nausea, diarrhoea, constipation and vomiting, and fatigue.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.