As reported on MedicalXpress, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for several therapies this cycle, including a conditional endorsement that could bring Novo Nordisk’s semaglutide to European patients with metabolic dysfunction–associated steatohepatitis (MASH). The recommendation positions the GLP‑1 agonist for a new indication under a separate brand name: Kayshild.
Semaglutide has been steadily expanding its clinical footprint, gaining U.S. approval in 2024 for treating MASH in selected adult patients. That authorization added to its existing indications in obesity and cardiovascular risk reduction. The CHMP’s latest stance aligns with the FDA’s earlier decision, signaling confidence in the drug’s potential to address a disease area historically marked by failed trials and limited treatment options.
While Novo Nordisk advanced, not all manufacturers saw green lights. Eli Lilly’s Mounjaro, already a major player in metabolic disease, fell short in its bid for a new cardiovascular indication. At the same time, Amgen’s Tavneos, which is already approved in Europe, is being re-evaluated following emerging questions around the integrity of data from its pivotal study.
The CHMP’s support for Kayshild marks a meaningful step for a patient population with few effective therapies. If the European Commission follows the committee’s recommendation—as it typically does—Novo Nordisk could soon add another high-impact metabolic indication to its growing European portfolio.
