The European Medicines Agency’s CHMP recommended against approving Eli Lilly’s tirzepatide (Mounjaro) for a heart‑failure indication while supporting Novo Nordisk’s semaglutide for a liver disease application. The committee found Lilly’s submission insufficient to support the heart‑failure claim, whereas the semaglutide dossier met CHMP criteria for hepatic outcomes. The split decision highlights divergent regulator assessments of incretin agents beyond metabolic indications and may influence sponsor strategies for label expansion and post‑market evidence generation. Companies will face differing pathways in Europe for cardiometabolic and hepatic claims.